Fiducial Deployment System With Dimpled Needle
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Solution Overview
Problem
Current fiducial placement techniques, especially in radiation therapy, face challenges such as the need for multiple percutaneous punctures, interference with ultrasound visualization due to air pockets, and size limitations in endoscopic procedures, which complicate the precise targeting of tumors while minimizing damage to healthy tissue.
Innovation Solution
A fiducial deployment system featuring a dimpled needle with a detent mechanism that allows for the controlled, serial deployment of multiple fiducials, each with a compressible splayed portion for retention and echogenic enhancement, facilitating precise placement under ultrasound guidance without the need for frequent reloading.
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 where larger needle size is required
Solution Approach 1:
The patent employs nested structures where the stylet is inserted within the needle, and multiple fiducials are loaded within the stylet. The stylet acts as a protective sheath that guides and delivers the fiducials through the needle to the target site, eliminating the need for separate loading procedures and reducing procedural complexity while maintaining placement accuracy
2Ease of operation
If air pockets are introduced during fiducial placement, then fiducials can be delivered, but ultrasound visualization is interfered with
Solution Approach 1:
The patent extracts the air pocket problem by designing a system where fiducials are delivered through a fluid-filled stylet rather than air-filled spaces. The stylet maintains a fluid environment that eliminates acoustic impedance mismatches, allowing clear ultrasound visualization throughout the fiducial delivery process while maintaining ease of operation
3Adaptability or versatility
If multiple percutaneous punctures are performed, then multiple fiducials can be placed in disparate locations, but the risk of infection increases and procedural complexity increases
Solution Approach 1:
The patent creates a universal placement system where a single needle-stylet assembly can deliver multiple fiducials to different target locations through one puncture. The stylet can be advanced to different depths and angles within the same puncture tract, enabling placement of multiple fiducials in disparate locations while minimizing puncture sites and reducing infection risk
4Measurement precision
If larger needle size is used for obese patients, then fiducials can be placed accurately, but the procedure becomes more painful and complex
Solution Approach 1:
The patent employs a flexible stylet with a thin-walled construction that can bend and conform to tissue planes while maintaining structural integrity. This flexible design allows the stylet to navigate through longer tissue depths in obese patients without requiring excessively large needle diameters, thereby maintaining target precision while reducing procedural pain and complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This system enables efficient, precise placement of multiple fiducials in disparate locations with reduced procedural complexity and improved echogenicity, enhancing visualization and minimizing tissue damage during radiation therapy.
Implementation Method 1
The outer surface of the cannula body is dimpled to enhance its ability to reflect ultrasound waves and thereby provide a desirable echogenic profile
Implementation Method 2
each of which is equipped with a compressible portion, where the compressible portion is configured to retain the fiducial until it is advanced to the dimpled retention means and sufficiently compressed to pass thereby and be deployed
Data Source
Figure 1A~1B
Figure 2A~2
AI summary
Embodiments include a fiducial deployment system including a needle and at least one splayed-end fiducial retained within the needle by frictional engagement and/or by engagement of the splayed end with one or more distal detents in the needle's lumen. A fiducial may include one or more splayed portions configured to engage the wall of the needle lumen, which may include one or more detents. The needle, which may include echogenic enhancements, may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time. A variety of splayed-portion fiducials are disclosed.