Vascular Access Analyte Sensor with Flow Control
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Solution Overview
Problem
Conventional methods for monitoring blood glucose levels in diabetic patients are invasive, inconvenient, and often fail to detect hyperglycemic or hypoglycemic conditions in a timely manner, leading to dangerous side effects due to the infrequent measurement intervals.
Innovation Solution
An integrated sensor system that includes an analyte sensor, a vascular access device, and a flow control system with a valve to regulate exposure to biological samples and a reference solution, allowing for continuous monitoring of glucose levels with improved accuracy and frequency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If single point blood glucose meter is used for measurement, then device complexity is reduced, but measurement precision and reliability deteriorate due to infrequent monitoring intervals
Solution Approach 1:
The patent implements continuous glucose monitoring by maintaining a catheter in the bloodstream that continuously draws blood samples through a membrane interface, enabling uninterrupted analyte detection. This continuous action eliminates the gaps inherent in single-point measurements while managing system complexity through automated operation.
Solution Approach 2:
The system performs preliminary calibration and priming actions during initial setup, including flushing the catheter with saline and establishing baseline measurements. This preliminary preparation ensures measurement precision is optimized before continuous monitoring begins, addressing accuracy concerns upfront.
2Measurement precision
If continuous monitoring is implemented, then measurement precision and reliability improve, but device complexity increases due to additional components
Solution Approach 1:
The catheter system serves multiple functions: it acts as both a sampling mechanism and a delivery vehicle for calibration solutions and flushing fluids. The single lumen design performs extraction, infusion, and cleaning functions sequentially, reducing overall device complexity while maintaining continuous monitoring precision.
Solution Approach 2:
The system incorporates automatic flushing capabilities using gravity flow or pump-driven mechanisms that self-clean the catheter and membrane interface without external intervention. This self-service feature maintains measurement precision by preventing clogging while minimizing the need for complex manual maintenance systems.
3Measurement precision
If frequent sampling is performed, then measurement precision improves, but loss of time increases due to sample processing requirements
Solution Approach 1:
The patent replaces manual blood drawing and laboratory analysis with an automated electrochemical sensing system. The membrane interface directly converts glucose concentration into electrical signals that are immediately processed and displayed, eliminating time-consuming mechanical sample handling and manual analysis steps while maintaining high measurement precision.
Solution Approach 2:
The system maintains continuous measurement capability by keeping the catheter primed and the membrane interface actively sampling at all times. This continuous operation eliminates idle time between measurements and ensures that glucose level changes are captured in real-time, maximizing measurement precision without time loss.
4Measurement precision
If vascular access device is used for continuous sampling, then measurement precision improves, but object-generated harmful factors increase due to potential complications
Solution Approach 1:
The catheter system is designed as a disposable component that is inserted for the duration of the monitoring period and then removed. This single-use approach eliminates the risk of long-term complications such as infection or thrombosis that could arise from prolonged vascular access, while still providing high-precision continuous measurements during the monitoring window.
Solution Approach 2:
The patent introduces a membrane interface as an intermediary between the blood and the sensing electrode. This membrane selectively allows glucose molecules to pass through while blocking blood cells and proteins, reducing the risk of clot formation and infection at the sampling site while maintaining accurate glucose measurement precision.
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 enables continuous, accurate monitoring of blood glucose levels, reducing the risk of undetected hyperglycemic or hypoglycemic events and allowing for more informed insulin therapy decisions.
Implementation Method 1
a sensor, which includes an electrochemical cell that provides output signals by which a presence or an absence of an analyte, such as glucose, in a sample can be determined
Implementation Method 2
In some conventional sensors, an enzyme is provided that reacts with the analyte to be measured, and the byproduct of the reaction is qualified or quantified at the electrode
Implementation Method 3
In one conventional amperometric glucose oxidase-based glucose sensor, immobilized glucose oxidase catalyses the oxidation of glucose to form hydrogen peroxide
Implementation Method 4
the valve is configured and arranged with a gravity flow position and a controlled flow position
Data Source
AI summary
Systems and methods of use for continuous analyte measurement of a host's vascular system are provided. In some embodiments, a continuous glucose measurement system includes a vascular access device, a sensor and sensor electronics, the system being configured for insertion into communication with a host's circulatory system.