Flow Modulator for Contrast Media Reflux Control
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Solution Overview
Problem
Current medical systems for delivering contrast media to coronary vasculature face challenges in minimizing systemic effects and optimizing delivery to specific sites, leading to inefficiencies and potential toxicity, especially in procedures like angiography and stenting, where contrast-induced nephropathy is a significant concern.
Innovation Solution
A medical system with a flow modulator that controls the delivery of contrast media by synchronizing injection pressure and flow rate with the natural cyclical flow of coronary blood, using mechanisms like single or double chamber modulators and constant force chambers to optimize delivery and reduce systemic reflux.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If contrast media is delivered systemically to coronary vasculature, then the intended diagnostic and therapeutic functions are achieved, but systemic toxicity and contrast-induced nephropathy occur
Solution Approach 1:
The patent applies local quality by delivering contrast media specifically to the coronary vasculature through a catheter-based injection system rather than systemic administration. The system enables localized contrast delivery to the target site (coronary arteries) while avoiding unnecessary systemic exposure, thereby maintaining diagnostic effectiveness while reducing nephrotoxicity risks
Solution Approach 2:
The patent uses an intermediary approach by introducing a collection device positioned in the coronary sinus to capture and divert contrast media that would otherwise reflux into the systemic circulation. This intermediary mechanism allows the contrast to fulfill its diagnostic function in the coronary arteries while preventing harmful systemic redistribution through the coronary sinus collection system
2Measurement precision
If contrast media injection pressure and flow rate are increased to improve delivery to the target site, then imaging quality and diagnostic accuracy improve, but the risk of contrast-induced nephropathy and systemic toxicity increases
Solution Approach 1:
The patent implements feedback control through a flow modulator that synchronizes contrast media injection with the natural cyclical flow of coronary blood. The system monitors blood flow patterns and adjusts injection timing and parameters accordingly, enabling optimal contrast delivery during phases of favorable blood flow while avoiding injection during phases that would increase systemic reflux and nephrotoxicity risk
Solution Approach 2:
The patent applies periodic action by synchronizing contrast media injection with the cyclical nature of coronary blood flow. The injection is timed to coincide with specific phases of the cardiac cycle when coronary flow patterns favor forward delivery to the target vessels, thereby achieving high imaging quality while minimizing backward reflux into systemic circulation
3Reliability
If a flow modulator is used to synchronize injection with coronary blood flow, then contrast delivery efficiency and safety improve, but device complexity increases
Solution Approach 1:
The patent applies self-service by designing a flow modulator that automatically synchronizes contrast injection with coronary blood flow patterns without requiring external control systems. The device utilizes the natural physiological cues of coronary flow to trigger and regulate injection timing, eliminating the need for complex external monitoring and control machinery while maintaining safety and efficiency
Data Source
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AI summary
A system (825) and method for collection and re-use of a fluid medium derived from the diversion of at least some of an injection of the medium to a selected site within a patient's body are described. The system includes a sterile medium container (328), a flow diverter assembly (575) disposed in a fluid medium flow path between an injection syringe (332) and a medium delivery catheter (334), and a diversion reservoir (827, 827a, 827b) having a reservoir chamber (860, 834) for receiving the diverted portion of the fluid medium from the flow diverter assembly (575) and a fluid coupling (588b) to the sterile medium container (328). The flow diverter assembly (575) is configured to divert at least a portion of a fluid medium injection from the medium flow path between the syringe (332) and the delivery catheter (334) during injection. The diversion reservoir (827, 827a, 827b) is configured so as to preferentially allow re-use of the diverted medium in the reservoir chamber (860, 834) prior to allowing use of the medium in the sterile medium container (328).