Pericardial Flushing System with Real-Time Hematocrit and Pressure Control
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Solution Overview
Problem
Current methods for postoperative pericardial cavity flushing after cardiac surgery are inadequate in preventing cardiac tamponade and excessive blood loss, as they rely on indirect monitoring and fail to accurately detect bleeding trends, leading to increased morbidity and mortality.
Innovation Solution
A flushing system equipped with volume, hematocrit, and pressure sensors that control the infusion liquid flow rate based on real-time sensor signals, allowing for precise monitoring and adjustment of blood loss and pressure in the pericardial cavity to prevent cardiac tamponade and reduce postoperative bleeding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If chest tubes are used to evacuate blood from the pericardial cavity, then blood drainage is provided, but the tubes fail when blood loss is excessive or clots develop rapidly, leading to stasis and cardiac tamponade
Solution Approach 1:
The flushing system performs preliminary action by continuously flushing the pericardial cavity with irrigation fluid before excessive blood accumulation occurs. The system proactively prevents clot formation and maintains patent drainage pathways, rather than waiting for drainage failure to occur. This is achieved through continuous low-level irrigation that keeps blood moving and prevents stasis.
Solution Approach 2:
The system implements continuous useful action through constant irrigation fluid flow through the pericardial cavity. Unlike intermittent chest tube drainage that fails when clots form, the continuous flushing action maintains ongoing evacuation of blood and prevents clot formation. The pump delivers irrigation fluid continuously, ensuring uninterrupted prevention of tamponade.
2Loss of information
If indirect monitoring methods (blood pressure, CVP) are used to detect cardiac tamponade, then monitoring is provided, but detection is delayed until it is too late for effective intervention
Solution Approach 1:
The system implements direct feedback by placing a pressure sensor inside the pericardial cavity to continuously monitor intrapericardial pressure. This provides real-time information about pressure changes, allowing immediate detection of tamponade development. The feedback loop enables the control system to respond instantly to pressure changes, eliminating the delayed indirect monitoring of blood pressure and CVP.
Solution Approach 2:
The invention replaces the indirect mechanical monitoring system (blood pressure cuff, CVP line) with a direct pressure sensing mechanism inside the pericardial cavity. The pressure sensor provides direct mechanical measurement of intrapericardial pressure, substituting the unreliable indirect methods that depend on patient position, transducer placement, and medication infusion interference.
3Measurement precision
If multiple sensors and control systems are added to enable real-time monitoring and control, then detection precision and control accuracy are improved, but device complexity increases
Solution Approach 1:
The system merges multiple functions into a single integrated flushing system. The irrigation fluid delivery, blood evacuation, pressure monitoring, and control functions are combined in one system rather than using separate chest tubes and monitoring devices. This integration reduces overall system complexity while maintaining high measurement precision through coordinated sensor and actuator operations.
Solution Approach 2:
The flushing system performs multiple functions simultaneously: it irrigates the pericardial cavity, evacuates blood through the same access point, monitors pressure, and controls flow rates. This multi-functionality eliminates the need for separate chest tubes and monitoring systems, reducing device complexity while improving measurement precision through unified sensor integration.
Data Source
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Figure 3a~3b
AI summary
The invention provides a flushing system (1) configured to flush the pericardial cavity (PC) of a patient, wherein the system comprises: an infusion liquid outlet (4) to connect a first tube(20) having an infusion liquid lumen to guide a flow of infusion liquid from the system to the pericardial cavity, and an effusion liquid inlet (6) to connect to a second tube (21) having an effusion liquid lumen to guide the effusion liquid flow from the pericardial cavity to the system, a flow rate control system to control the flow rate of the infusion liquid flow at the infusion liquid outlet (4) on the basis of multiple sensor signals, wherein the flow rate control system comprises: a control unit (5) to provide a control signal on the basis of the sensor signals, and a pump device (3) to pump infusion liquid to the infusion liquid outlet (4) at an infusion liquid flow rate, wherein the infusion liquid flow rate is adjustable by the control signal of the control unit (5) and wherein the sensor signals registered by the control unit (5) comprise: an infusion liquid signal representative for the infusion liquid flow to the pericardial cavity, an effusion liquid signal representative for the effusion liquid flow rate from the pericardial cavity, a blood volume signal generated by a hematocrit sensor (12) representative for a blood loss flow rate in the effusion liquid from the pericardial cavity, and a pressure control signal representative for the pressure in the pericardial cavity generated by a pressure sensor positioned inside or in connection with the first tube (20), the second tube (21) or the pericardial cavity. The invention also provides a method of monitoring the blood loss volume or flow rate from the pericardium based on multiple sensor signals as well as. a method of treatment of postoperative cardiac patients in order to reduce the risk of cardiac tamponade, reduce post-operative blood loss and reduce the accumulation of blood and clots in the pericardial cavity, wherein the pericardial cavity of the patient is flushed with a flushing system according to the invention.