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

VSEngineering 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

Engineering Contradiction:
Improvefiducial placement accuracyVSAvoidplacement procedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

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

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If air pockets are introduced during fiducial placement, then fiducials can be delivered, but ultrasound visualization is interfered with

Engineering Contradiction:
Improvefiducial delivery easeVSAvoidultrasound visualization quality
Core Design Contradiction:
Ease of operationVSDifficulty of detecting and measuring

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

Inventive Principle:
Principle #2Taking out (Extraction)

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

Engineering Contradiction:
Improvemultiple target location capabilityVSAvoidinfection risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

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

Inventive Principle:
Principle #6Universality (Multi-functionality)

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

Engineering Contradiction:
Improvetarget location precisionVSAvoidprocedural comfort
Core Design Contradiction:
Measurement precisionVSEase of operation

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

Inventive Principle:
Principle #30Flexible shells and thin films

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

Methodology Applied
Scientific EffectEcho: Echo

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

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP2725990B1System for fiducial deployment
Publication Date: 2018.05.30 COOK MEDICAL TECHNOLOGIES LLC
  • EP2725990B1 patent drawingFigure 1A~1B
  • EP2725990B1 patent drawingFigure 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.