Smart Obturator with Sensor for IV Catheter Occlusion Prevention

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Solution Overview

Problem

Conventional obturators used in IV catheters are prone to causing patient infection and fail to effectively prevent occlusion due to clotting blood, bio-films, and fibrin formation, requiring frequent replacement and risking reflux of blood back into the catheter.

Innovation Solution

A smart obturator assembly with a sensor at the distal end that senses environmental characteristics, such as markers and chemicals in the blood stream, and transmits signals to electronic circuitry for remote reception or display, while maintaining a fluid-tight seal and preventing occlusion through a customizable interface with the catheter.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a conventional solid plastic obturator is used to seal the IV catheter, then the catheter opening is closed to prevent blood reflux, but the risk of patient infection increases

Engineering Contradiction:

Improveprevention of blood refluxVSAvoidpatient infection risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The obturator is designed to be removed and discarded after a single use, extracting the infection risk from the system. The obturator is inserted to prevent blood reflux during the procedure, then removed to eliminate the infection hazard, allowing the catheter to be safely removed without leaving foreign material in the blood vessel.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The obturator is designed as a disposable single-use component. It is inexpensive, single-use, and discarded after performing its function of preventing blood reflux during the catheter procedure, thereby eliminating long-term infection risks while maintaining effective protection during use.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

2Reliability

If a conventional obturator is used to prevent occlusion, then blood flow is maintained, but frequent catheter replacement is required

Engineering Contradiction:

Improveprevention of occlusionVSAvoidcatheter replacement frequency

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The obturator incorporates sensors that provide feedback about blood flow conditions, clot formation, and occlusion risks in real-time. This feedback allows the system to detect when the obturator is failing to prevent occlusion or when the catheter should be removed, enabling timely intervention and reducing unnecessary replacements while maintaining effective occlusion prevention.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The mechanical obturator system is enhanced with electronic sensing and communication capabilities. Instead of relying solely on mechanical sealing, the system uses sensors to detect blood flow status, clot formation, and occlusion risks, providing intelligent control that extends catheter usability and reduces replacement frequency.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If the IV catheter remains open after use, then blood can reflux back into the catheter tip, but clotting and bio-film formation obstruct blood flow

Engineering Contradiction:

Improvecatheter accessibilityVSAvoidblood flow patency

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The obturator is inserted into the catheter before the catheter is removed from the patient, performing the preliminary action of sealing the catheter opening and preventing blood reflux. This preliminary sealing action prevents clot formation and bio-film development that would otherwise obstruct blood flow, maintaining patency until the obturator is removed.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The obturator serves as an intermediary element between the catheter and the blood vessel. It seals the catheter opening to prevent blood reflux while allowing controlled access during the procedure, then is removed to eliminate the barrier that would otherwise cause clotting and obstruction, maintaining blood flow patency.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS11185259B2Smart obturator with sensor and smart obturator assembly

Publication Date: 2021.11.30 BECTON DICKINSON & CO

AI summary

An obturator assembly includes an obturator at least partially positionable within a lumen of a device. The obturator has a distal end with a tip portion and an opposing proximal end. A sensor assembly is at the tip portion. The sensor assembly is configured to sense one or more environmental characteristics and to generate one or more signals representative of the one or more environmental characteristics. A hub is operatively coupled to the obturator. The hub is also operatively coupled to electronic circuitry that is coupled in signal communication with the sensor assembly. In certain embodiments, the electronic circuitry is configured to receive the one or more signals from the sensor assembly and transmit the one or more signals to remote reception circuitry and/or display a datum representative of the one or more environmental characteristics on a display of the hub.