Extracorporeal Fetal Support System with Passive Oxygenation
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Solution Overview
Problem
Extreme prematurity is the leading cause of infant morbidity and mortality in the United States, with respiratory failure being the most common and challenging problem due to the structural and functional immaturity of the lungs in preterm neonates, especially those born before 28 weeks gestation.
Innovation Solution
A system and method are described that provide extracorporeal support for a premature fetus, including a chamber configured to enclose a fetus and a system for providing oxygen, which connects to the fetus's umbilical cord to facilitate gas exchange and potential medication delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional extracorporeal membrane oxygenation (ECMO) with pump support is used to achieve adequate oxygenation of the fetus, then oxygenation is improved, but circulatory overload and cardiac failure occur due to after-load or pre-load imbalance imposed on the fetal heart
Solution Approach 1:
The patent removes the pump component from the extracorporeal circulation system, extracting the harmful mechanical assistance that causes circulatory overload. The system relies on the fetus's own cardiac pump to maintain circulation, eliminating the after-load and pre-load imbalance that leads to cardiac failure while still providing adequate oxygenation through membrane oxygenation.
Solution Approach 2:
The patent introduces a membrane oxygenator as an intermediary device that performs gas exchange without requiring mechanical pump support. This intermediary component enables oxygenation while maintaining a simple circulatory circuit that avoids imposing additional mechanical stress on the fetal heart.
2Reliability
If traditional extracorporeal membrane oxygenation systems are used to support fetal life, then oxygenation is achieved, but contamination and fetal sepsis occur
Solution Approach 1:
The patent divides the extracorporeal support system into separate functional modules: a membrane oxygenator for gas exchange and a separate reservoir for fluid management. This segmentation allows for better control of the circulatory circuit, reducing the risk of contamination by isolating potential contamination sources and enabling more rigorous sterilization protocols.
Solution Approach 2:
The system is designed to be self-regulating through passive membrane oxygenation that does not require external mechanical intervention. This self-service approach minimizes the number of invasive connections and mechanical components that could serve as contamination vectors, thereby reducing the risk of fetal sepsis.
3Reliability
If a closed chamber configuration is used to enclose the fetus, then a controlled environment is created, but access for procedures is limited
Solution Approach 1:
The patent incorporates a movable partition wall that can dynamically adjust the configuration of the chamber. This dynamic element allows the chamber to transition between a closed controlled environment and an open accessible configuration, enabling procedures to be performed while maintaining the benefits of a controlled fetal environment.
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 aims to improve the viability of premature fetuses by providing a controlled extracorporeal environment that mimics in-utero conditions, reducing morbidity and mortality associated with extreme prematurity.
Implementation Method 1
a second fluid circuit including an oxygenator configured to transfer oxygen to the fetus
Data Source
AI summary
A system and method to deliver a medicant to a premature fetus in an extracorporeal environment. Exemplary medicants include at least one selected from stem cells and modified genes. The system can include a chamber to enclose the fetus, a first fluid circuit including a source of a liquid, a pump configured to move the liquid, and a second fluid circuit including an oxygenator configured to transfer oxygen to the fetus. The umbilical cord of the fetus is connected to the second fluid circuit by attaching a first cannula connected to a vein of the umbilical cord, attaching a second cannula to a first artery of the umbilical cord, attaching a third cannula to a second artery of the umbilical cord, and connecting one or more of the first, second and third cannulae to the oxygenator via an oxygenation circuit.