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 measurements and lack of trend analysis.

Innovation Solution

An integrated sensor system that includes an analyte sensor, a vascular access device, and a flow control device to regulate exposure to biological samples and a reference solution, allowing for continuous monitoring of glucose levels with a system comprising a catheter, sensors, and a flow control mechanism to manage sample exposure and infusion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If single point blood glucose measurement is used, then device complexity is reduced, but measurement precision and reliability are insufficient for continuous monitoring

Engineering Contradiction:
Improvedevice complexityVSAvoidmeasurement precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The sensor system is divided into multiple electrodes (working electrode, counter electrode, reference electrode) with distinct functions, allowing continuous monitoring while maintaining manageable complexity through modular design

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter system serves multiple functions: vascular access for fluid infusion, blood sampling for analyte measurement, and continuous monitoring capability, reducing the need for separate devices

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Measurement precision

If frequent blood glucose measurements are performed, then measurement precision improves, but ease of operation deteriorates due to invasive procedures

Engineering Contradiction:
Improvemeasurement precisionVSAvoidease of operation
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

An enzyme layer (glucose oxidase) acts as an intermediary between glucose molecules and the electrode, enabling non-invasive continuous monitoring through interstitial fluid rather than requiring repeated blood draws

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The mechanical finger-pricking method is replaced with an electrochemical sensing system that continuously measures glucose through a catheter, eliminating the need for repeated invasive procedures

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If enzyme is added to enhance analyte detection, then measurement precision improves, but device complexity increases

Engineering Contradiction:
Improvemeasurement precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The enzyme layer is integrated directly onto the electrode surface within the catheter assembly, combining the biochemical detection function with the electrical sensing function in a single unified structure

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

A thin film containing the enzyme (glucose oxidase) is applied to the electrode surface, providing the necessary biochemical functionality while maintaining a compact and manageable device structure

Inventive Principle:
Principle #30Flexible shells and thin films

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, 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

an analyte (or a species derived from it) that is electro-active generates a detectable signal at an electrode

Methodology Applied
Scientific EffectElectrochemical reaction:

Implementation Method 2

In one conventional amperometric glucose oxidase-based glucose sensor, immobilized glucose oxidase catalyses the oxidation of glucose to form hydrogen peroxide

Methodology Applied
Scientific EffectEnzyme catalysis: Enzyme

Implementation Method 3

the valve is configured and arranged with a gravity flow position and a controlled flow position

Methodology Applied
Scientific EffectGravity flow: Gravitation

Data Source

PatentUS8886273B2Analyte sensor
Publication Date: 2014.11.11 DEXCOM INC
  • US8886273B2 patent drawing
  • US8886273B2 patent drawing
  • US8886273B2 patent drawing

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.