Fiducial Deployment System Serial Delivery
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Solution Overview
Problem
Current methods for placing fiducials in medical procedures, especially for radiation therapy, face challenges such as the need for multiple percutaneous punctures, interference with ultrasound visualization due to air pockets, and limitations in fiducial size and reloading processes, which complicate precise targeting of tumors within the body.
Innovation Solution
A fiducial deployment system featuring slotted needles and fiducials with protuberances that allow for serial delivery and controlled placement of multiple fiducials without manual reloading, enhancing echogenicity and usability in ultrasound-guided procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If percutaneous placement of fiducials is used, then fiducials can be inserted into the patient, but the procedure becomes complex and painful especially for obese patients requiring larger needle sizes
Solution Approach 1:
Multiple fiducials are nested within a single needle lumen, allowing sequential deployment of multiple fiducials through one puncture site. The fiducials are arranged in a train configuration where each fiducial can be deployed by advancing the needle a specific distance and releasing the stylet, eliminating the need for multiple separate punctures and reducing procedural complexity.
2Reliability
If traditional fiducial deployment methods are used, then fiducials can be placed, but air pockets interfere with ultrasound visualization
Solution Approach 1:
The stylet is completely removed from the needle lumen after fiducial deployment, eliminating air pockets that would otherwise remain and interfere with ultrasound visualization. This extraction of the air-containing component (stylet) resolves the visualization problem while maintaining the benefit of accurate fiducial placement.
3Quantity of substance
If manual reloading of fiducials is required, then fiducials can be placed sequentially, but procedural time and complexity increase
Solution Approach 1:
Multiple fiducials are pre-loaded into the needle lumen in a train configuration before the procedure begins. The fiducials are positioned sequentially within the needle, with each fiducial at a predetermined distance from the needle tip. This preliminary arrangement allows rapid sequential deployment without time-consuming manual reloading during the procedure.
4Reliability
If larger needle sizes are used for obese patients, then fiducials can be inserted, but the procedure becomes more painful and complex
Solution Approach 1:
The procedure is segmented into controlled stages where the needle is advanced in increments corresponding to the spacing between fiducials. Each fiducial is deployed at a specific depth by advancing the needle a predetermined distance and releasing the stylet. This segmentation allows precise control of the insertion process, reducing pain and complexity even in obese patients by avoiding the need for excessively large bore needles.
Data Source
AI summary
Embodiments include a fiducial deployment system with a handle configured for actuation of same. A fiducial may include one or more protuberances configured to engage one or more slots in a needle of the system. The needle may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. In certain embodiments, echogenic placement of fiducials may present certain advantages. The handle may include structures configured for incrementally or otherwise controlledly deploying one or more fiducials by advancing a stylet through and/or retracting the body of a needle in which fiducials are disposed.