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 configured to measure glucose levels in a biological sample, a vascular access device, and a flow control device to regulate exposure to a biological sample and a reference solution, allowing for continuous monitoring and minimizing invasive procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If single point blood glucose measurement is used, then the device complexity is low, but the measurement frequency is insufficient leading to undetected hyperglycemic or hypoglycemic conditions
Solution Approach 1:
The patent implements continuous glucose monitoring by maintaining a catheter in the bloodstream that continuously samples glucose levels, eliminating the need for repeated finger pricks. The flow control device enables continuous or periodic exposure of the sensor to blood samples, providing ongoing measurement capability rather than single-point measurements.
Solution Approach 2:
The patent introduces a flow control device as an intermediary component that regulates blood flow to the sensor. This device acts as a mediator between the bloodstream and the sensor, controlling the exposure timing and flow rate to optimize measurement frequency while managing system complexity.
2Measurement precision
If frequent blood sampling is performed, then the measurement precision and timeliness improve, but the invasiveness and burden on patients increase
Solution Approach 1:
The patent performs preliminary action by inserting a catheter into the bloodstream in advance, establishing continuous access for glucose sampling. This initial invasive step enables subsequent non-invasive or minimally invasive continuous monitoring, reducing the need for repeated skin punctures.
Solution Approach 2:
The patent replaces the mechanical finger-pricking method with a catheter-based blood sampling system. Instead of repeatedly penetrating the skin, a single catheter insertion provides continuous access to blood samples, substituting a more complex initial mechanical setup with simpler ongoing monitoring.
3Loss of time
If continuous monitoring is implemented, then the loss of time for detecting glucose trends is reduced, but the device complexity and flow control requirements increase
Solution Approach 1:
The patent implements periodic action by using the flow control device to regulate blood exposure to the sensor at controlled intervals or flow rates. This periodic sampling approach enables trend detection over time while managing the complexity of continuous flow control, allowing the system to capture glucose dynamics without requiring constant high-speed sampling.
4Measurement precision
If enzyme-based sensing is used, then the measurement specificity to glucose improves, but the sensor sensitivity to interferents and baseline drift increases
Solution Approach 1:
The patent applies local quality by using enzyme coating specifically at the sensor surface where glucose detection occurs. The enzyme layer provides localized specificity to glucose at the critical measurement interface, while the rest of the system (flow control, catheter) handles the broader challenges of sample delivery and interferent management.
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
Enables continuous, non-invasive 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
an analyte (or a species derived from it) that is electro-active generates a detectable signal at an electrode
Implementation Method 2
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
a flow control device configured to regulate exposure of the analyte sensor to a biological sample and to a reference solution according to a flow profile
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.