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 a tubing assembly and free-flow mitigation device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If single point blood glucose measurement is used, then the measurement method is simple, but the monitoring frequency is insufficient leading to undetected hyperglycemic or hypoglycemic conditions

Engineering Contradiction:
Improvemonitoring frequencyVSAvoidsystem complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent implements continuous glucose monitoring by maintaining a catheter in the bloodstream with an enzyme electrode that continuously measures glucose levels. The system provides uninterrupted monitoring through continuous exposure to biological sample, eliminating the need for repeated finger pricks and enabling detection of hyperglycemic or hypoglycemic events as they occur.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The patent employs a nested structure where the enzyme electrode is positioned within the catheter lumen. The catheter serves as an outer structure that delivers and positions the sensing element directly in the bloodstream, creating a hierarchical arrangement that enables continuous monitoring while maintaining a relatively simple overall system architecture.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Reliability

If frequent blood sampling is performed to improve monitoring accuracy, then the detection reliability improves, but the patient discomfort and operational burden increase

Engineering Contradiction:
Improvedetection reliabilityVSAvoidpatient comfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The continuous monitoring system maintains constant exposure of the enzyme electrode to glucose in the bloodstream through the catheter, providing uninterrupted detection without requiring repeated blood draws. This eliminates patient discomfort associated with frequent finger pricks while maintaining high detection reliability through continuous data acquisition.

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The catheter acts as an intermediary device that bridges the external monitoring system and the internal bloodstream environment. It delivers the enzyme electrode into direct contact with blood glucose while minimizing patient discomfort by avoiding repeated invasive procedures, thus improving ease of operation while maintaining detection reliability.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If continuous monitoring system is implemented, then the monitoring accuracy improves, but the device complexity and cost increase

Engineering Contradiction:
Improvemonitoring accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The nested arrangement of the enzyme electrode within the catheter lumen creates a compact integrated system. This hierarchical structure allows continuous monitoring functionality to be achieved without requiring multiple separate components, thereby improving measurement precision while controlling overall system complexity through efficient spatial arrangement.

Inventive Principle:
Principle #7Nested doll (Nesting)

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 enzyme electrode that measures glucose by exposure to the biological sample

Methodology Applied
Scientific EffectElectrochemical reaction: Redox Reactions

Implementation Method 2

an enzyme electrode that measures glucose

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

PatentUS8478377B2Analyte sensor
Publication Date: 2013.07.02 DEXCOM INC
  • US8478377B2 patent drawing
  • US8478377B2 patent drawing
  • US8478377B2 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.