Biopsy Needle Tip Marker Deployment for Accurate Site Placement
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Solution Overview
Problem
Existing biopsy devices face challenges in accurately and reliably deploying markers at biopsy sites, particularly due to the limitations of deploying markers through lateral apertures, which can interfere with tissue sampling and result in inaccurate marker placement.
Innovation Solution
A biopsy device with a needle featuring a marking lumen that deploys markers through the tissue piercing tip, combined with a bioabsorbable carrier and a non-absorbable marker element, allowing for precise and reliable marker placement using mechanisms like push rods or pressurized fluids.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If markers are deployed through lateral aperture of biopsy needle, then marker placement can be performed using existing needle structure, but marker placement accuracy and reliability deteriorate due to interference with tissue sampling
Solution Approach 1:
The needle structure is segmented into multiple functional lumens: a biopsy lumen for tissue sampling and a separate marking lumen for marker deployment. This segmentation allows independent optimization of each function, with the marking lumen positioned to not interfere with tissue sampling through the biopsy lumen, thereby achieving both marker deployment capability and high placement accuracy.
Solution Approach 2:
A dedicated marking lumen acts as an intermediary pathway for marker deployment, separate from the biopsy sampling pathway. This intermediary structure enables marker delivery without compromising the tissue sampling function, resolving the conflict between versatility and precision.
2Device complexity
If biopsy needle is used for both sampling and marker deployment, then device complexity is reduced, but reliability of marker placement deteriorates
Solution Approach 1:
The biopsy needle is designed with multi-functionality, incorporating both biopsy sampling and marker deployment capabilities within a single integrated device. The needle includes a biopsy lumen for tissue sampling and a marking lumen for marker delivery, allowing one device to perform multiple functions reliably without requiring separate instruments.
Solution Approach 2:
The internal structure of the needle is segmented into distinct lumens for different functions. The marking lumen is specifically configured with its own pathway, allowing reliable marker deployment independent of the biopsy sampling process, thereby maintaining high reliability while keeping the overall device structure relatively simple.
3Manufacturing precision
If marker deployment path is separated from tissue sampling path, then marker placement accuracy is improved, but device complexity increases
Solution Approach 1:
The marking lumen is nested within the wall structure of the biopsy needle, utilizing the needle wall itself as part of the marking lumen pathway. This nesting approach allows for accurate marker placement through a dedicated pathway while minimizing the increase in device complexity, as the marking lumen is integrated into the existing needle structure rather than adding a completely separate component.
Data Source
AI summary
A system for marking a biopsy site includes a biopsy device and a biopsy site marker. The biopsy device includes a body and a needle. The needle extends distally from the body and includes a tissue piercing tip. The needle defines an axial lumen and a lateral lumen. The axial lumen is configured to receive a cutter therein. The tissue piercing tip defines a marking lumen in communication with the lateral lumen. The biopsy site marker includes a non-absorbable marker element and a bioabsorbable carrier. The marker element is at least partially disposed within the carrier. The biopsy site marker is configured for receipt within the marking lumen of the needle.