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 to measure analyte concentrations in a biological sample, allowing for continuous monitoring and infusion of a reference solution to regulate sensor exposure, thereby improving the accuracy and frequency of glucose level readings.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If single point blood glucose measurement is used, 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 sensor in the bloodstream that continuously measures glucose levels, eliminating the discontinuous nature of fingerstick measurements. The sensor provides uninterrupted data flow, allowing real-time detection of hyperglycemic and hypoglycemic events without requiring repeated patient interventions.
Solution Approach 2:
The patent introduces an intermediary reference solution flushing system that periodically cleans the sensor surface by flushing with a known concentration solution. This intermediary mechanism maintains sensor accuracy without requiring direct patient blood sampling, resolving the contradiction between continuous monitoring and measurement precision.
2Measurement precision
If continuous monitoring with reference solution flushing is implemented, then measurement precision improves, but device complexity and loss of substance increase
Solution Approach 1:
The patent employs periodic flushing cycles where the reference solution is intermittently pumped through the sensor rather than continuous flushing. This periodic action maintains sensor precision by regularly cleaning the sensor surface while minimizing reference solution consumption and reducing the complexity of the flow control system compared to continuous operation.
Solution Approach 2:
The system incorporates automatic self-flushing capabilities where the sensor cleans itself using the reference solution without requiring manual intervention. The flow control device automatically manages the flushing cycles, maintaining measurement precision while minimizing the need for external control mechanisms.
3Measurement precision
If frequent blood sampling is performed, then measurement precision improves, but loss of time and ease of operation deteriorate due to patient burden
Solution Approach 1:
The continuous in vivo sensor eliminates the need for repeated fingerstick procedures by providing uninterrupted glucose monitoring through a single initial vascular insertion. This continuous measurement approach achieves high measurement precision while dramatically improving patient convenience by removing the recurring burden of frequent blood sampling.
4Measurement precision
If reference solution is continuously infused to maintain sensor accuracy, then measurement precision improves, but loss of substance and use of energy increase
Solution Approach 1:
The system uses intermittent periodic flushing with reference solution rather than continuous infusion. This approach maintains sensor calibration accuracy by periodically renewing the reference solution contact with the sensor surface while significantly reducing the total volume of reference solution consumed compared to continuous infusion methods.
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, thereby improving patient safety and reducing healthcare workload.
Implementation Method 1
a first analyte sensor (120) configured and arranged for measuring an analyte concentration in a biological sample
Implementation Method 2
the flow control device comprises a valve, and wherein 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.