Vacuum Pressure Regulator With Flexible Membrane for Blood Draw Stability

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Solution Overview

Problem

The collapse of a patient's blood vessel during blood collection occurs due to the rapid flow rate caused by the instantaneous vacuum pressure applied by evacuated tubes, leading to vessel wall collapse and potential flow stoppage.

Innovation Solution

A vacuum pressure regulator with a flexible member that modulates the flow rate by restricting the fluid passageway in response to differential pressure, slowing down the initial flow rate and preventing vessel collapse, featuring a tubular sidewall with a flexible member that can collapse to restrict the flow area and include a venturi channel for accelerated flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If an evacuated tube is connected to a blood collection set, then blood is drawn into the tube, but the instantaneous vacuum pressure causes a spiked flow rate that leads to vessel collapse

Engineering Contradiction:
Improveblood collection efficiencyVSAvoidvessel collapse
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

A regulator device is introduced as an intermediary component between the evacuated tube and the blood collection set. This regulator includes a flexible membrane that automatically modulates the vacuum pressure transmission, creating a buffer that prevents the instantaneous pressure spike from reaching the blood vessel while still allowing effective blood collection

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The regulator dynamically changes the vacuum pressure parameter transmitted to the blood collection system. By using a flexible membrane with specific elasticity characteristics, the system transforms the instantaneous high-pressure vacuum into a controlled, gradual pressure application that maintains blood flow without causing vessel collapse

Inventive Principle:
Principle #35Parameter changes

2Speed

If vacuum pressure is applied to draw blood, then blood flows into the collection tube, but the flow rate is too rapid causing vessel wall collapse against the cannula bevel

Engineering Contradiction:
Improveblood flow rateVSAvoidcontinuous flow
Core Design Contradiction:
SpeedVSReliability

Solution Approach 1:

The regulator employs a dynamic flexible membrane that automatically adjusts its resistance to vacuum pressure based on the instantaneous pressure conditions. As vacuum pressure increases, the membrane deflects to reduce flow; as pressure equalizes, the membrane returns to allow normal flow. This dynamic adjustment ensures continuous, stable blood flow without sudden spikes that cause vessel collapse

Inventive Principle:
Principle #15Dynamics

3Ease of manufacture

If standard evacuated tubes are used, then blood collection is performed, but the instantaneous vacuum pressure spike cannot be minimized

Engineering Contradiction:
Improvesimplicity of blood collection deviceVSAvoidinitial pressure spike
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

A regulator device is introduced as an intermediary component between the evacuated tube and the blood collection set. This regulator includes a flexible membrane that automatically modulates the vacuum pressure transmission, creating a buffer that prevents the instantaneous pressure spike from reaching the blood vessel while still allowing effective blood collection

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The regulator dynamically changes the vacuum pressure parameter transmitted to the blood collection system. By using a flexible membrane with specific elasticity characteristics, the system transforms the instantaneous high-pressure vacuum into a controlled, gradual pressure application that maintains blood flow without causing vessel collapse

Inventive Principle:
Principle #35Parameter changes

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 regulator effectively minimizes vessel collapse by controlling the flow rate, preventing rapid depletion of blood and ensuring continuous blood collection by maintaining a stable flow path through automatic and optional manual regulation.

Implementation Method 1

Upon the exposure of the fluid transfer device to a differential pressure, the flexible member is configured for movement with respect to the fluid passageway to modulate a flow rate of the fluid

Methodology Applied
Scientific EffectDifferential pressure: Pressure Gradient

Implementation Method 2

The flexible member can comprise a spring element... the flexible member is configured for movement with respect to the fluid passageway... the flexible member can be configured to at least partially collapse toward the fluid passageway to restrict a flow area

Methodology Applied
Scientific EffectFlexible member collapse: Deformation

Implementation Method 3

A venturi channel can be associated with the flexible member which can be adapted to accelerate the flow of fluid through an area adjacent the flexible member upon exposure to the differential pressure

Methodology Applied
Scientific EffectVenturi effect: Venturi Effect

Data Source

PatentEP2996741B1Vacuum pressure regulators for use during blood collection
Publication Date: 2021.02.24 BECTON DICKINSON & CO
  • EP2996741B1 patent drawingFigure 1~1B
  • EP2996741B1 patent drawingFigure 2~2C
  • EP2996741B1 patent drawingFigure 3

AI summary

A regulator for in-line modulation of the flow rate of fluid during blood collection includes a fluid transfer device for transferring fluid from a patient to a collection device. The fluid transfer device comprises a fluid passageway defined by a tubular sidewall and a flexible member associated with a portion of the tubular sidewall. The flexible member is configured for movement with respect to the fluid passageway upon exposure of the fluid transfer device to a differential pressure during a blood collection procedure to prevent collapse of a patients blood vessel. The flexible member of the regulator can be a frame surrounding a flexible diaphragm. Alternatively, the flexible member can include a flexible material integrally formed within the tubular sidewall of the pressure regulator.