Smart artificial lung and perfusion systems
Inventors
POTKAY, Joseph • Bartlett, Robert H. • ROJAS-PENA, Alvaro
Assignees
Potkay Joseph • US Department of Veterans Affairs • University of Michigan Ann Arbor
Publication Number
US-12233189-B2
Publication Date
2025-02-25
Expiration Date
2039-06-18
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Abstract
An artificial lung system for a patient having a membrane lung system having an gas inlet, a blood inlet, a blood outlet, and an exhaust; a gas system operably coupled to the gas inlet of the membrane lung system; a gas phase CO2 sensor disposed downstream of the exhaust of the membrane lung system and monitoring an exhaust gas CO2 (EGCO2) level and/or an blood oxygen saturation sensor disposed upstream of the blood inlet of the membrane lung system and monitoring a blood oxygen saturation level; and a feedback controller receiving the CO2 signal and/or blood oxygen saturation signal and outputting a control signal to control gas flow and/or blood flow.
Core Innovation
The invention provides a smart artificial lung and perfusion system that automatically adjusts CO2 clearance and oxygen delivery according to the patient's changing metabolic needs. It includes a membrane lung system with a gas inlet, blood inlet, blood outlet, and exhaust, coupled with a gas system supplying air or gas to the membrane lung. A gas phase CO2 sensor monitors exhaust gas CO2 (EGCO2) downstream of the membrane lung exhaust, and a blood oxygen saturation sensor (including SvO2) monitors blood oxygenation upstream of the blood inlet. A feedback controller, such as a proportional-integral-derivative (PID) controller, receives signals from these sensors to adjust sweep gas flow and blood flow to optimize CO2 removal and oxygen delivery.
The problem addressed is that existing artificial lung systems and mechanical ventilators cannot automatically respond to the patient's dynamically changing physiological requirements. Current systems risk removing too much CO2 during rest or improved lung function or insufficient CO2 during activity or disease exacerbation, limiting patient comfort, activity, and rehabilitation potential. Manual adjustments by medical staff are imprecise and delayed. The invention solves this by providing an automated control system that continuously monitors exhaust gas CO2 and blood oxygen saturation to modulate sweep gas and blood flows rapidly and precisely, improving patient management, comfort, and outcome.
The invention also introduces a novel smart artificial lung design optimized for CO2 removal using a gated concentric design that enhances flow mixing, minimizes stagnant flow and thrombosis, and uses PMP fibers with a short gas flow path to maintain gas gradients and reduce condensation. This design, combined with the automated controller, enables efficient and dynamic respiratory support, applicable to traditional, ambulatory, and wearable artificial lung systems for end-stage lung disease (ESLD) patients. The system is designed to be compact, battery-operated, and integrated for clinical use with compliance to FDA design controls.
Claims Coverage
The patent includes one independent claim that covers an artificial lung system comprising a membrane lung, gas system, CO2 sensor, and a feedback controller, and details several inventive features regarding system components and their interaction for automated respiratory support.
Automated CO2 removal control based on exhaust gas CO2 measurement
The system uses a gas phase CO2 sensor located downstream of the membrane lung exhaust that outputs a CO2 signal which is fed to a feedback controller. The controller adjusts sweep gas flow automatically such that if the exhaust gas CO2 content rises above a target level, sweep flow increases to remove more CO2; if it decreases, sweep flow decreases to reduce CO2 removal.
Integration of water trap to protect CO2 sensor functionality
A water trap is disposed between the membrane lung exhaust and the gas phase CO2 sensor to prevent condensate from affecting sensor accuracy and performance.
Monitoring of blood oxygen saturation upstream of the membrane lung
The system includes a blood oxygen saturation sensor, such as an oximeter or SvO2 sensor, positioned upstream of the blood inlet of the membrane lung to monitor blood oxygenation, providing signals to the feedback controller for respiratory management.
Automated blood flow control based on blood oxygen saturation
The feedback controller receives blood oxygen saturation signals and outputs blood flow control signals to modulate blood flow through the membrane lung to meet oxygenation needs.
Flexible gas system configurations for sweep gas supply
The gas system feeding the membrane lung gas inlet can comprise components such as gas cylinders, oxygen concentrators, and gas flow controllers, operably controlled by the feedback controller.
Use of proportional-integral-derivative (PID) feedback control
The feedback controller comprises a PID controller to regulate sweep gas flow and blood flow based on sensor inputs to maintain desired CO2 and oxygenation levels.
The claims collectively cover a smart artificial lung system with integrated sensors and a PID feedback controller that automatically adjusts sweep gas flow and blood flow to optimize CO2 removal and oxygen delivery, incorporating features to ensure sensor functionality and flexible gas supply configurations.
Stated Advantages
Automatic, rapid, and precise adjustment of CO2 removal and oxygen delivery to meet the patient's changing metabolic needs.
Improved patient comfort, activity, and rehabilitation potential by maintaining blood gas levels within desired ranges.
Reduced need for manual intervention by healthcare staff, lowering workload and potential for delayed or imprecise adjustments.
Compatibility with traditional, ambulatory, and wearable artificial lung systems, enabling greater patient mobility and potential for home use.
Improved patient safety due to fast control reference tracking and good disturbance rejection under varying physiological conditions.
Efficient gas exchange through the novel membrane lung design minimizing stagnant flow and thrombosis.
Documented Applications
Respiratory support for patients with end-stage lung disease (ESLD) including chronic obstructive pulmonary disease (COPD) and acute respiratory distress syndrome (ARDS).
Bridge to lung transplantation by providing artificial lung support during waiting periods.
Use in intensive care units (ICU) to augment existing extracorporeal membrane oxygenation (ECMO) and ambulatory ECMO systems for automated CO2 clearance control.
Integration into ambulatory and wearable artificial lung systems to enable patient mobility and potential home use.
Automated oxygen delivery management during veno-arterial ECMO based on mixed venous oxygen saturation.
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