Multi-Modality Site Marker for Biopsy Localization
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Solution Overview
Problem
Existing site markers for breast biopsy procedures are not visible under multiple imaging modalities, necessitating additional procedures for precise localization of biopsy sites during cancer treatment.
Innovation Solution
Development of site markers made from biocompatible materials, such as titanium, stainless steel, or platinum, designed to be visible under various imaging techniques, including radiographic, ultrasonic, and MRI modalities, with configurations that expand post-deployment to prevent migration and enhance visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a site marker is made visible under multiple imaging modalities, then the precision of localization is improved, but the device complexity increases
Solution Approach 1:
The site marker employs composite materials with distinct radiographic and ultrasonic properties. The marker body contains radiopaque material for X-ray visibility while incorporating ultrasonic reflective surfaces or interfaces for ultrasound detection, allowing simultaneous visualization under multiple imaging modalities without requiring separate markers
Solution Approach 2:
The site marker is designed as a multi-functional device that serves multiple purposes: it provides radiographic visibility for mammography and X-ray imaging, ultrasonic visibility for ultrasound guidance, and physical anchoring within the biopsy cavity. This consolidation of multiple functions into a single device reduces the need for additional procedural interventions
2Reliability
If a site marker is designed to prevent migration, then the reliability is improved, but the ease of operation deteriorates
Solution Approach 1:
The site marker features a dynamic deployment mechanism that transitions from a compressed delivery configuration to an expanded deployed configuration. During delivery, the marker is compressed within the biopsy needle for easy insertion. After deployment, the marker expands to engage tissue anchors or barbs that prevent migration, thus achieving both ease of operation during insertion and reliability during retention
Solution Approach 2:
The site marker is divided into functional segments: a delivery portion that facilitates insertion through the biopsy needle, and a retention portion with tissue-engaging features such as barbs or anchors that deploy after insertion to prevent migration. This segmentation allows the marker to be easily delivered while providing reliable long-term stabilization
Data Source
AI summary
A site marker is provided that includes a generally hollow body defining a cavity. A deployment line within the site marker positions at least one marker element within the body portion. The deployment line has a first end that is fixedly secured to a first end of the body portion and a second end that is secured to a second end of the body portion. The deployment line is pre-biased so as to pull the first end of the body portion towards the second end of the body portion, and thereby expand the body portion.