Implantable Fluid Management System for Chronic Ascites
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Solution Overview
Problem
Current treatments for chronic ascites, pleural effusion, and pericardial effusion are invasive, prone to complications, and require frequent interventions, leading to patient discomfort, increased risk of infection, and high economic burdens due to the need for repeated procedures and plasma expanders.
Innovation Solution
An implantable fluid management system comprising a pump, controller, battery, and sensors that autonomously and periodically removes fluid in small increments, reducing the risk of clogging and infection, and includes a charging and communication system for remote monitoring and control, allowing for programmed operation and alerting physicians of potential infections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If repeated paracentesis is performed to drain ascitic fluid, then fluid accumulation is reduced, but patient quality of life deteriorates and infection risk increases
Solution Approach 1:
The implantable pump system operates autonomously to drain ascitic fluid without requiring repeated manual paracentesis procedures. The pump self-regulates fluid removal based on programmed parameters, eliminating the need for frequent hospital visits and needle insertions, thereby improving patient quality of life while maintaining effective fluid management.
Solution Approach 2:
The patent replaces the mechanical intervention of repeated needle insertion and manual drainage with an implantable electromechanical pump system. This substitution eliminates the traumatic aspect of repeated paracentesis while providing continuous, controlled fluid removal, reducing infection risk and improving patient comfort.
2Quantity of substance
If large volumes of ascitic fluid are removed periodically, then fluid accumulation is reduced, but fluid equilibrium disturbance occurs requiring plasma expander infusion
Solution Approach 1:
The implantable pump performs periodic, small-volume fluid removal rather than single large-volume drainage. This distributed periodic action maintains fluid equilibrium by removing fluid gradually over time, preventing sudden shifts in circulating blood volume and eliminating the need for plasma expander infusions.
Solution Approach 2:
The patent segments the total fluid removal volume into multiple small increments delivered over time. This segmentation approach prevents disturbance of fluid equilibrium and circulating blood volume, avoiding the need for plasma expander therapy while still achieving effective ascites management.
3Productivity
If implantable pump operates continuously, then fluid management effectiveness increases, but pump or catheter blockage risk increases
Solution Approach 1:
The pump operates in periodic cycles with intermittent rest periods rather than continuous operation. During rest periods, the system can clear blockages through reverse flow or pressure equalization, maintaining reliability while achieving effective fluid management over the full operational cycle.
Solution Approach 2:
The patent incorporates dynamic operation modes including forward flow, reverse flow, and pressure-regulated pausing. These dynamic adjustments allow the system to respond to blockage conditions by reversing flow direction or modifying pressure gradients, maintaining both effectiveness and reliability.
4Device complexity
If manual activation of pump is required, then device complexity is reduced, but patient compliance deteriorates
Solution Approach 1:
The pump system operates autonomously based on pre-programmed parameters set by the physician. The device self-regulates fluid removal without requiring patient intervention or manual activation, ensuring consistent compliance while maintaining relatively simple operation through programmable control.
Solution Approach 2:
The implantable system incorporates sensors that monitor fluid pressure and volume, providing feedback to the control circuitry. This feedback mechanism allows automatic adjustment of pump operation based on real-time conditions, maintaining effectiveness while requiring minimal patient input or compliance efforts.
Data Source
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AI summary
The present invention relates to a fluid management system (10) comprising an implantable device (20) comprising a housing (21) containing a positive displacement gear pump coupled to an electric motor (73) and a first controller (70) coupled to a first battery (74), a first transceiver (76), and a first inductive charging circuit (75); a charging and communication system (30) comprising a second controller (152) coupled to a second transceiver (155) and a second inductive charging circuit (156), the charging and communication system configured to wirelessly communicate with the implantable device via the first and second transceivers, and to wirelessly transfer energy from the second inductive circuit to the first inductive circuit to charge the first battery; and monitoring and control software (40, 180) configured to run on a computer, the monitoring and control software configured to communicate operational parameters to the implantable device via the charging and communication system to control operation of the motor and gear pump.