Endoscopic Ultrasound Fiducial Marker System with Multi-Stop Stylet Spacer
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Solution Overview
Problem
The current methods for implanting multiple fiducial markers into tissue during radiation therapy are cumbersome and risky, involving repeated needle removal and reloading, which increases procedure duration and risk of injury, and can lead to inaccurate placement due to difficulty in controlling the deployment of multiple markers.
Innovation Solution
A device and system utilizing a needle and stylet with a multi-stop stylet spacer that allows controlled deployment of multiple fiducial markers by adjusting the stylet spacer to predetermined positions, preventing accidental deployment and enabling precise placement through tactile feedback, reducing the need for manual reloading and enhancing safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If multiple fiducial markers are loaded into the needle at once, then the number of manual reloading operations is reduced, but it becomes difficult to controllably implant a single fiducial marker at a time, leading to inaccurate placement
Solution Approach 1:
The needle is divided into multiple chambers, each capable of holding a separate fiducial marker. This segmentation allows the system to maintain multiple markers ready for implantation while enabling controlled release of individual markers through selective chamber activation, thus resolving the conflict between having multiple markers available and being able to implant them one at a time with precision.
Solution Approach 2:
The needle system incorporates dynamic control mechanisms that allow the operator to selectively activate or deactivate specific chambers based on the implantation sequence. This dynamic control enables the system to transition from a static multi-marker configuration to a controlled single-marker release mechanism, maintaining both productivity and precision.
2Ease of operation
If the needle is repeatedly removed from the delivery system and manually reloaded, then each fiducial marker can be individually loaded, but the procedure duration increases and the risk of injury to patient and clinician increases
Solution Approach 1:
Multiple fiducial markers are pre-loaded into separate chambers of the needle before the procedure begins. This preliminary action eliminates the need for repeated manual reloading operations during the procedure, significantly reducing procedure duration and minimizing the time the needle is outside the delivery system, thereby reducing injury risk while maintaining operational control.
Solution Approach 2:
Multiple fiducial markers are nested within separate chambers inside the needle lumen. This nested configuration allows multiple markers to be contained within the single needle structure, enabling all markers to be introduced into the target tissue in one procedure without repeated needle insertions and reloads.
3Ease of operation
If the entire delivery system is removed from the body each time a new fiducial marker is loaded, then the needle can be reloaded, but this increases the risk of injury and extends procedure time
Solution Approach 1:
All fiducial markers are pre-loaded into the needle chambers before the needle is inserted into the patient. This preliminary preparation eliminates the need to remove and reload the needle during the procedure, maintaining the needle continuously within the sterile delivery system and minimizing exposure risks to both patient and clinician.
Solution Approach 2:
The needle system is designed to be self-sufficient with multiple pre-loaded chambers, eliminating the need for external reloading operations. The system performs its own marker delivery function without requiring removal from the delivery system, thereby maintaining safety and reliability throughout the procedure.
4Productivity
If multiple fiducial markers are loaded into the needle, then efficiency is improved, but it becomes difficult to achieve adequate spacing between each implanted marker
Solution Approach 1:
The needle is segmented into multiple distinct chambers, each housing a fiducial marker. This segmentation provides physical separation between markers within the needle, and when combined with controlled release mechanisms, enables precise spacing control during implantation while maintaining the efficiency of having all markers pre-loaded and ready for deployment.
Data Source
AI summary
Methods, apparatuses and systems are described for implanting a plurality of fiducial markers into a tissue. Systems include a needle, a stylet sized to slide within a lumen of the needle, and a multi-stop stylet spacer having stopping features configured to engage with the stylet to stop the distal end of the stylet at one or more predetermined distances from the distal end of the needle. Methods for implanting a plurality of fiducial markers into a tissue are described and include inserting a needle preloaded with fiducial markers into a tissue, adjusting a multi-stop stylet spacer from a safety position to a first deployment position, deploying a first fiducial marker into the tissue, adjusting the stylet spacer from the first deployment position to a second deployment position, and deploying a second fiducial marker into the tissue.