Sensor System With Segmented Calibration And Sample Paths

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Solution Overview

Problem

Current intravascular and ex-vivo sensor systems for sensing analytes in bodily fluids require calibration and anticoagulants, leading to unnecessary administration of fluids and potential removal of large blood volumes, which is undesirable.

Innovation Solution

A sensor system with a calibration path and a sample path that isolates fluid flow, allowing the sensor to move between configurations for calibration and sensing, using a valve to prevent fluid exchange and minimize anticoagulant administration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the sensor is continuously exposed to bodily fluid for sensing, then the sensing function is maintained, but calibration becomes difficult and fluid contamination occurs

Engineering Contradiction:

Improvesensing functionVSAvoidfluid path configuration

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The fluid handling system is divided into two separate paths: a first fluid path for calibration fluid and a second fluid path for bodily fluid. The sensor can be selectively positioned in either path, allowing independent calibration and sensing operations without cross-contamination or complex switching mechanisms.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A valve assembly acts as an intermediary mechanism that controls the positioning of the sensor between the calibration path and the sensing path. This mediator enables the sensor to access both fluid paths sequentially without direct fluid exchange between the paths, maintaining system simplicity while enabling dual functionality.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If calibration fluid is administered to the patient during sensing, then the sensor can be calibrated in vivo, but harmful fluid administration occurs

Engineering Contradiction:

Improvesensor calibrationVSAvoidcalibration fluid administration

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system separates calibration and sensing operations into distinct fluid paths. The first fluid path is dedicated to calibration fluid delivery to the sensor, while the second path handles bodily fluid sampling. This segmentation allows calibration to occur without introducing calibration fluid into the patient's vasculature, eliminating the harmful effect while maintaining calibration precision.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The calibration function is extracted from the patient's body and performed in a separate calibration path. The sensor can be calibrated using calibration fluid in the first path before being positioned in the second path for bodily fluid sensing, or calibrated externally without fluid administration to the patient.

Inventive Principle:

Principle #2Taking out (Extraction)

3Quantity of substance

If large blood volumes are removed for ex-vivo sensing, then adequate sample is available for analysis, but patient harm increases

Engineering Contradiction:

Improveblood sample volumeVSAvoidblood volume removal

Core Design Contradiction:

Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The sensor positioning is made dynamic, allowing the sensor to be moved between the calibration path and the sensing path as needed. This dynamic positioning enables the sensor to be calibrated in the first path and then immediately used in the second path with minimal blood volume requirement, as the sensor does not need to be continuously exposed to large blood volumes for calibration.

Inventive Principle:

Principle #15Dynamics

4Stability of the object's composition

If anticoagulants are infused with calibration fluid, then the calibration path remains clear, but the patient receives unnecessary anticoagulants

Engineering Contradiction:

Improvecalibration path patencyVSAvoidanticoagulant administration

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The system segregates the calibration fluid path from the patient's body. Anticoagulants can be added to the calibration fluid in the first path to prevent clotting in the calibration tubing and sensor, but since this path is separate from the patient's vasculature, the anticoagulants do not enter the patient's body, eliminating unnecessary medication exposure.

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS9907503B2Sensor systems and methods of using the same

Publication Date: 2018.03.06 BD SWITZERLAND SARL

AI summary

Provided are sensor systems and methods for detecting analytes of bodily fluids. The systems can be used to reduce the administration volume of certain compounds and/or fluids during medical monitoring or other procedures by providing a calibration path configured to receive a first fluid, a sample path isolated from the calibration path, the sample path configured to receive a bodily fluid from a subject, and a sensor apparatus comprising at least one sensor selectively positionable between the calibration path and the sample path.