Flow Sensor Connection Assembly for Documented IV Bolus Delivery

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Solution Overview

Problem

There is a need to reduce medication errors during intravenous bolus delivery at the bedside by providing an automated record of medication administration and alerting healthcare professionals when delivery is inconsistent with a patient's medical record.

Innovation Solution

A flow sensor system comprising a single-use flow sensor and a reusable base unit, which includes sensors to characterize fluid attributes and generate operation modification signals for wireless transmission, ensuring accurate and documented bolus delivery, with features like cantilevered wings for secure mounting and a vault for protection against contamination.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a flow sensor system is implemented to provide automated monitoring and documentation of bolus delivery, then medication safety and measurement precision are improved, but device complexity increases

Engineering Contradiction:
Improvemedication safetyVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The flow sensor system is divided into two separable components: a disposable flow sensor component and a reusable base unit. The disposable component contains the flow sensor, fluid pathway, and associated electronics, while the reusable base unit houses the controller, power source, and communication interfaces. This segmentation allows the complex sensing and control functions to be isolated in a disposable unit, reducing the complexity burden on the permanent installation while maintaining high reliability through automated monitoring and documentation of each bolus delivery event.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A cross-component electrical circuit is established through a connection assembly that includes conductive elements on both the disposable flow sensor and the reusable base unit. This intermediary electrical connection enables the disposable sensor to communicate flow measurements and operational status to the reusable controller without requiring permanent wiring, thus improving medication safety through automated data capture while managing device complexity by allowing easy replacement of the sensor component.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a disposable flow sensor with reusable base unit is used, then ease of operation and reliability are improved through standardized connections, but manufacturing precision requirements increase

Engineering Contradiction:
Improveease of operationVSAvoidmanufacturing precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The reusable base unit is designed with a standardized connection interface that can accommodate different disposable flow sensor components. The connection assembly includes universal electrical contacts and mechanical coupling features that work across multiple sensor types and revisions. This universality improves ease of operation by allowing healthcare providers to quickly swap sensors without complex calibration or reconfiguration, while the standardized design actually reduces manufacturing precision requirements compared to custom-fitted solutions.

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

Solution Approach 2:

The connection assembly incorporates compliance features such as spring-loaded electrical contacts and flexible circuit board traces that can accommodate variations in assembly tolerances. These parameter changes in the electrical connection design allow for easier manufacturing of both the disposable and reusable components while maintaining reliable electrical connectivity for flow measurement and control signals.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If electrical connections are made through a connection assembly, then ease of operation is improved through plug-and-play functionality, but reliability may be compromised by connection variability

Engineering Contradiction:
Improveease of operationVSAvoidelectrical connection reliability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The flow sensor is implemented as a disposable component that is replaced after each use or after a limited number of uses. This eliminates the accumulation of connection wear and degradation over time, maintaining reliable electrical connections for the lifespan of each sensor while allowing healthcare providers to quickly swap to a fresh unit. The disposable nature ensures that connection interfaces never degrade from repeated mating cycles, preserving electrical reliability without compromising plug-and-play ease of operation.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The connection assembly is designed with built-in compliance features such as spring elements and flexible traces that compensate for minor misalignments and tolerance variations before they can affect electrical contact quality. This beforehand cushioning of potential connection issues ensures reliable signal transmission for flow measurements and control commands while maintaining the simple plug-and-play interface that improves ease of operation.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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

The system effectively reduces medication errors by providing real-time monitoring and automatic documentation of bolus delivery, ensuring accurate recording and alerting healthcare professionals to potential inconsistencies, thus enhancing patient safety.

Implementation Method 1

first and a second piezo elements that are mounted to the end fittings

Methodology Applied
Scientific EffectPiezoelectric effect: Piezoelectric Effect

Implementation Method 2

The system incorporates rules-based clinical decision support logic to drive a flow control valve within a flow pathway... Preferably, the system has an ultrasonic flow sensor

Methodology Applied
Scientific EffectUltrasonic measurement: Ultrasound

Data Source

PatentEP3804782B1Flow sensor system with connection assembly
Publication Date: 2023.07.26 CRISI MEDICAL SYSTEMS INC
  • EP3804782B1 patent drawingFigure 1
  • EP3804782B1 patent drawingFigure 2
  • EP3804782B1 patent drawingFigure 3A~3B

AI summary

A system for sensing medicament delivery and transmitting an operation modification signal having at least two separable components is disclosed. The system includes a flow sensor having an inlet to couple to a fluid source, an outlet for delivering fluid from the fluid source to a patient, at least one sensor to characterize at least one attribute of the fluid, and at least one pin in in electrical communication with the sensor. The system includes a second component having a base having a contact, a controller in electrical communication with the contact that generates an operation modification signal in response to an attribute matching a condition specified by a rule, a transmitter for transmitting the operation modification signal to a device, the operation modification signal, when received by the device, causing the device to modify at least one operating parameter, and a cross-component electrical circuit.