Customizable Saturation Biopsy Grid for Prostate Positioning Accuracy
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Solution Overview
Problem
Current trans-rectal biopsy techniques for prostate cancer diagnosis face high false positive rates, positional inaccuracies, and low repeatability, prompting the need for improved methods to accurately sample and manage prostate tissue.
Innovation Solution
A customizable saturation biopsy system that includes a pathology mapping unit with a grid assembly and display to identify and mark specific regions of the prostate, using either a controllable electromagnetic or visually projected grid, to guide needle insertion and provide detailed information on grid location and disease analysis.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If trans-rectal biopsy technique is used, then biopsy can be performed, but false positive rate is high and positional accuracy is poor
Solution Approach 1:
The prostate gland is divided into eight distinct sub-regions (octants) for systematic sampling. The grid assembly divides the biopsy area into multiple defined regions, allowing targeted sampling from each sub-region to improve positional accuracy and reduce false positives by ensuring comprehensive coverage.
Solution Approach 2:
A grid assembly is introduced as an intermediary tool between the ultrasound imaging system and the biopsy needle. This grid serves as a reference framework that overlays the ultrasound images and guides needle insertion, providing a mediator that improves positional accuracy without requiring direct manual estimation.
2Reliability
If trans-rectal biopsy technique is used, then biopsy can be performed, but repeatability of results and sampling positions is low
Solution Approach 1:
The grid assembly is pre-configured and overlaid on the ultrasound images before biopsy sampling begins. This preliminary establishment of a reference framework ensures that all subsequent needle insertions can be consistently mapped to the same anatomical regions, improving repeatability across multiple biopsies and sampling positions.
Solution Approach 2:
The system provides visual feedback by displaying the grid overlay on real-time or pre-acquired ultrasound images. This feedback mechanism allows the operator to verify needle position relative to the grid-defined regions, ensuring consistent sampling locations and improving repeatability through continuous positional verification.
3Measurement precision
If saturation biopsy with multiple core samples is performed, then diagnostic accuracy improves, but procedure complexity increases
Solution Approach 1:
The grid assembly serves multiple functions simultaneously: it provides a visual reference overlay on ultrasound images, defines the eight sub-regions for sampling, guides needle insertion positions, and tracks sampling progress. This multi-functionality reduces procedure complexity by consolidating multiple guidance tasks into a single integrated tool.
Solution Approach 2:
The grid assembly creates a visual copy or representation of the prostate's anatomical structure overlaid on the ultrasound images. This copied reference framework simplifies the complex task of navigating three-dimensional anatomy by providing a two-dimensional map that guides needle insertion, making the multi-sample saturation biopsy procedure more manageable.
Data Source
AI summary
A system and method for customized saturation biopsy is provided that facilitates diagnosis, management and treatment of cancer or other disease in a gland or organ. The system includes a pathology mapping unit that identifies a plurality of regions of a biopsy area. A grid assembly is coupled to the pathology mapping unit, the grid assembly including a grid disposed externally to the biopsy area. A display is coupled to the pathology mapping unit that displays information corresponding to the plurality of regions of the biopsy area, the pathology mapping unit controlling a configuration of the grid and the information corresponding to the plurality of regions. An image probe can be provided that acquires at least one image of the biopsy area, and the display displays the at least one image. An interface can be provided that is coupled to the display and supplies information to the pathology mapping unit.