Flexible Membrane Pressure Detection for Infusion Safety

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Solution Overview

Problem

Current infusion devices lack effective methods for detecting pressure fluctuations in gravity-based infusion systems and near the patient, leading to potential harm from excessive pressure and false alarms due to improper placement of infusion bags or Y-valves.

Innovation Solution

A disposable pressure detection system with a flexible membrane that changes shape in response to pressure changes, providing a visual indication and reducing peak pressures through an overflow mechanism, and utilizing an image sensing device to read markings on the membrane for precise pressure measurement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Power

If a mechanical syringe is used for fluid delivery, then high pressure (>80 psi) can be generated, but this places both the product and the patient at risk of damage or injury

Engineering Contradiction:
Improvepressure generation capabilityVSAvoidpatient damage risk
Core Design Contradiction:
PowerVSObject-affected harmful factors

Solution Approach 1:

A compliant membrane is introduced as an intermediary component between the fluid delivery system and the patient. The membrane deforms under pressure to provide visual indication and can be designed to fail safely by creating an overflow path, preventing excessive pressure transmission to the patient while maintaining the ability to deliver high pressure when needed for proper fluid administration

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If pressure sensors are built into infusion devices to detect pressure spikes, then occlusions upstream or downstream can be detected, but there are no known methods for detecting pressure fluctuations in gravity-based infusion or in the infusion line closer to the patient

Engineering Contradiction:
Improvepressure detection capabilityVSAvoidapplicability to different infusion types
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The system uses the pressure itself to activate the indication mechanism. The compliant membrane automatically deforms and provides visual feedback when pressure exceeds safe levels, eliminating the need for external power sources, electronics, or complex sensor systems. This passive operation enables universal application across different infusion types including gravity-based systems where electronic sensors may not be feasible

Inventive Principle:
Principle #25Self-service

3Ease of operation

If pre-configured pressure values are set in infusion devices, then pressure limits can be established, but these values are either fixed with limited ranges or require caregiver adjustment, and the acquired value during power-on is over a defined range

Engineering Contradiction:
Improvepressure limit settingVSAvoidpressure threshold accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The pressure indication device is designed as a disposable component that can be attached to the infusion line. Each device comes pre-calibrated with a specific pressure threshold appropriate for its application. The device is single-use, eliminating the need for complex adjustment mechanisms or calibration procedures, while ensuring consistent and accurate pressure indication for each patient

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

4Illumination intensity

If the flexible membrane expands to indicate pressure increase, then visual indication of overpressure is provided, but the distance the identification mechanism travels must be sufficient to be visible yet not excessive

Engineering Contradiction:
Improvevisual indication visibilityVSAvoidmembrane expansion distance
Core Design Contradiction:
Illumination intensityVSLength of stationary object

Solution Approach 1:

A thin, compliant membrane is used that can deform significantly under pressure. The membrane is engineered with appropriate thickness and material properties to provide adequate deformation distance for clear visual indication while maintaining structural integrity and preventing excessive expansion that would compromise the device function or patient safety

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

Effectively detects overpressure events, reduces peak pressures, and provides accurate pressure readings to prevent patient harm and false alarms, enhancing the safety of infusion procedures.

Implementation Method 1

configured to change shape and expand responsive to an increase in pressure caused by the fluid accumulated within the chamber

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

utilizing an image sensing device to read markings on the membrane for precise pressure measurement

Methodology Applied
Scientific EffectOptical detection: Photography

Data Source

PatentUS20230390491A1Pressure detection system and method
Publication Date: 2023.12.07 CAREFUSION 303 INC
  • US20230390491A1 patent drawing
  • US20230390491A1 patent drawing
  • US20230390491A1 patent drawing

AI summary

A pressure detection system includes a body having an internal chamber with input and output ports and a flexible membrane fluidically sealed to an exposed opening of the chamber to prevent a fluid passing through the chamber from passing through the exposed opening. The membrane is configured to change shape responsive to an increase in pressure caused by the fluid within the chamber satisfying a predetermined threshold. In some implementations, the membrane includes or is part of an identification mechanism which moves outwards, away from the chamber, as the pressure increases to indicate the pressure increase. In some implementations, the identification mechanism includes markings on the surface of the membrane, and an image sensing device reads the markings, and provides an indication of a current pressure associated with the fluid in the chamber based on a variation in the markings from a default state.