Adjustable Shunt Pediatric ECMO Circuit Design

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Solution Overview

Problem

Current pediatric ECMO circuits face challenges with low blood flow rates, leading to thrombus formation and the need for frequent circuit replacement, which can cause inflammatory reactions and morbidity/mortality, especially in neonatal applications where anticoagulant levels must be minimized to avoid 'brain bleeds'.

Innovation Solution

The design incorporates a medium diameter venous and arterial line system with adjustable shunts and a stopcock to control blood flow, reducing connectors in the patient blood path and increasing overall blood flow through the oxygenator, while maintaining adequate flow to the patient, using specific tubing sizes and connectors to enhance blood flow and minimize thrombus formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If low blood flow rates are used in pediatric ECMO circuits, then anticoagulant levels can be minimized to avoid brain bleeds in neonates, but thrombus formation increases and requires frequent circuit replacement

Engineering Contradiction:
Improvebrain bleedsVSAvoidcircuit durability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The circuit is divided into multiple shunt lines with adjustable flow control, allowing segmentation of blood flow paths. This enables independent control of flow distribution between the patient and the shunt, permitting optimization of anticoagulation levels while maintaining adequate flow rates to prevent thrombus formation in the oxygenator.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The shunt lines incorporate adjustable flow control mechanisms (such as flow meters or adjustable clamps) that allow dynamic modification of blood flow rates. This dynamic adjustability enables the system to adapt flow rates to match patient needs while maintaining sufficient flow through the oxygenator to prevent thrombus formation, even at lower overall blood flow rates.

Inventive Principle:
Principle #15Dynamics

2Reliability

If higher blood flow rates are used through the oxygenator, then thrombus formation is prevented, but the required blood flow to the patient may exceed prescribed levels

Engineering Contradiction:
Improvethrombus preventionVSAvoidblood flow to patient
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The blood flow is segmented into multiple paths: the primary path through the patient and secondary paths through the shunt lines. This segmentation allows the system to deliver the required blood flow to the patient while simultaneously maintaining adequate flow rates through the oxygenator via the shunt, preventing thrombus formation without exceeding prescribed patient flow levels.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Flow control mechanisms in the shunt lines provide feedback on blood flow rates, allowing real-time adjustment. This feedback enables the system to maintain adequate flow through the oxygenator to prevent thrombus formation while ensuring the blood flow to the patient remains within prescribed levels, through continuous monitoring and adjustment.

Inventive Principle:
Principle #23Feedback

3Adaptability or versatility

If multiple connectors are placed in the patient blood path for sampling and medication, then access for monitoring and treatment is improved, but each connector becomes a location for thrombus deposition

Engineering Contradiction:
Improveaccess for monitoringVSAvoidthrombus formation
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The shunt lines are extracted as separate access points from the main patient blood path. This extraction allows sampling and medication administration to be performed through the shunt lines rather than at multiple connectors in the primary circuit, reducing the number of potential thrombus deposition sites in the patient blood path while maintaining necessary access for monitoring and treatment.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS20230381491A1Adjustable Shunt Pediatric/Neonatal ECMO Circuit
Publication Date: 2023.11.30 ALDRIDGE ALFRED LEE
  • US20230381491A1 patent drawing
  • US20230381491A1 patent drawing
  • US20230381491A1 patent drawing

AI summary

Embodiments provide an extra corporeal membrane oxygenation circuit, wherein a pump communicates blood from a patient to an oxygenator and thence back to the patient, comprising: a medium diameter venous line configured to accept blood from the patient and communicate the blood to the pump; a medium diameter arterial line configured to accept blood from the oxygenator and communicate the blood to the patient; one or more shunts connected in a series; wherein a first of such shunts is connected to accept blood from the venous line in parallel with the pump and wherein a last of such shunts is connected to communicate blood to the arterial line.