Modulator with Constant Force Spring for Contrast Media Delivery
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Solution Overview
Problem
Current methods for delivering radiopaque contrast media to vascular sites are inefficient, leading to systemic reflux and toxicity, particularly in procedures like coronary angiography, where contrast-induced nephropathy is a significant concern, and existing solutions are either costly, cumbersome, or ineffective in optimizing delivery to specific sites while minimizing systemic effects.
Innovation Solution
A system comprising an injector, a delivery catheter, and a modulator with a medium reservoir and manifold that regulates pressure and flow rate to ensure precise delivery of contrast media, minimizing systemic reflux by maintaining a pre-determined maximum pressure and optimizing delivery to the intended site, synchronized with the natural flow patterns of the coronary arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If high flow rates are used to deliver contrast media quickly, then productivity is improved, but harmful factors increase due to systemic reflux and contrast-induced nephropathy
Solution Approach 1:
The modulator device creates different flow conditions at different locations: high flow rate at the delivery site (coronary artery) for effective visualization, while simultaneously maintaining low flow rate at the systemic circulation level to prevent nephropathy. This is achieved through the constant force spring mechanism that applies localized pressure control.
Solution Approach 2:
The system dynamically changes the flow rate parameter from high (during injection) to low (during delivery) by using a constant force spring mechanism. The spring maintains a predetermined force that limits the maximum flow rate, transforming the delivery profile from uncontrolled high flow to controlled low flow automatically.
2Reliability
If high pressure injection is used to overcome vascular resistance, then delivery effectiveness is improved, but harmful factors increase due to contrast media reflux into systemic circulation
Solution Approach 1:
The modulator transforms the pressure parameter from high (injection pressure) to low (delivery pressure) by using a constant force spring mechanism. The spring absorbs excess pressure energy and maintains a predetermined maximum pressure level, preventing reflux while ensuring adequate delivery pressure.
Solution Approach 2:
The constant force spring acts as an intermediary between the injector and the delivery catheter. It mediates the pressure transmission by converting high-pressure injection into controlled low-pressure delivery, preventing direct high-pressure reflux into systemic circulation.
3Illumination intensity
If large volumes of contrast media are injected, then visualization quality is improved, but loss of substance increases due to systemic distribution
Solution Approach 1:
The modulator ensures that contrast media is delivered with high concentration and flow rate locally at the coronary artery site for effective visualization, while the constant force spring mechanism prevents excessive systemic distribution by limiting overall flow rate and pressure.
4Device complexity
If manual injection methods are used, then device complexity is reduced, but manufacturing precision deteriorates due to inability to control flow rate and pressure
Solution Approach 1:
The constant force spring mechanism is a passive, self-regulating device that automatically maintains predetermined force without requiring external control systems. This achieves precise flow rate control through mechanical means alone, eliminating the need for complex electronic controllers while maintaining manufacturing precision.
Solution Approach 2:
The modulator uses a mechanical spring-based hydraulic system to control fluid flow. The constant force spring creates a predetermined pressure that automatically regulates the contrast media flow rate, achieving precise control through purely mechanical means without electronics.
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
The system effectively reduces the risk of contrast-induced nephropathy by optimizing the delivery of contrast media to specific vascular sites, minimizing systemic toxicity, and reducing the amount of media needed for effective visualization, thereby enhancing procedural efficiency and patient safety.
Implementation Method 1
The constant force spring is capable of imparting a constant pressure force on a fluid within a chamber
Implementation Method 2
The chamber is capable of acting as a pressure capacitor for the medium, being charged in the first instance by medium flowing from the injector into the chamber, and discharged in the second instance by fluid flowing from the chamber into the delivery catheter
Data Source
AI summary
Devices, systems and methods for controlling, regulating, altering, transforming or otherwise modulating the delivery of a substance to a delivery site. The devices, systems and methods optimize the delivery of the substance to an intended site, such as a vessel, vascular bed, organ and/or other corporeal structures, while reducing inadvertent introduction or reflux substance to other vessels, vascular beds, organs, and/or other structures, including systemic introduction.