Balloon Catheter Fluid Management for Single-Operator Cooling
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Solution Overview
Problem
Conventional balloon catheters face challenges in maintaining lower pressure inflation while keeping the balloon and catheter components cool, and require multiple operators for inflation and deflation, which limits their effectiveness in medical procedures like atrial fibrillation treatment.
Innovation Solution
A balloon catheter system with a fluid management system that includes a reservoir, conduits, and a pump for circulating fill media, allowing for controllable inflation and deflation, and a valve assembly that enables single-operator control through three distinct positions for inflation, deflation, and circulation, maintaining the balloon at a constant volume to prevent overheating.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the balloon is inflated to lower pressures (2-5 PSI or lower) to achieve greater contact with patient tissue, then the contact quality improves, but the cooling capability deteriorates because lower flow rates are required which are inadequate to keep the balloon and catheter components cool
Solution Approach 1:
The system dynamically adjusts the pump flow rate independently of balloon pressure. The pump can operate at high flow rates to provide adequate cooling even when the balloon is inflated at low pressures (2-5 PSI or lower) for better tissue contact. This decoupling of pressure control from flow rate control allows simultaneous optimization of both contact quality and cooling capability.
Solution Approach 2:
The system changes the operating parameters by maintaining a fixed relationship between inflation pressure and volume through coordinated control of the inflation valve and pump flow rate. This allows the balloon to be inflated to lower pressures for better contact while the pump continues to deliver sufficient flow rates for effective cooling, resolving the trade-off between contact quality and cooling capability.
2Ease of operation
If a separate remote operator is used to inflate or deflate the balloon catheter, then inflation control is achieved, but the operational complexity increases requiring at least two operators
Solution Approach 1:
The system merges the functions of balloon inflation control and fill media circulation control into a single integrated valve assembly that can be operated by one operator. The first valve controls both inflation pressure and fill media flow rate, while the second valve controls deflation and pump operation. This consolidation eliminates the need for a separate remote operator, reducing the required staff from at least two operators to a single operator.
Solution Approach 2:
The valve assembly is designed with multi-functionality to perform multiple operations: controlling balloon inflation pressure, regulating fill media flow rate for cooling, enabling deflation, and coordinating pump operation. This universal control mechanism allows a single operator to manage all aspects of balloon catheter operation, eliminating the need for specialized remote operators.
3Temperature
If the balloon is maintained at constant volume during circulation mode, then overheating is prevented, but the system complexity increases requiring a three-position valve assembly and coordinated pump control
Solution Approach 1:
The system uses dynamic coordination between the pump and valve assembly to maintain constant balloon volume during circulation mode. The pump delivers fill media to the balloon while the first valve adjusts to maintain constant volume, and the second valve routes the circulating media. This dynamic control prevents overheating by ensuring continuous circulation while maintaining stable balloon dimensions, with the control complexity managed through coordinated operation of the pump and valves.
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
Enables precise control of balloon pressure, maintains the balloon and catheter components at a safe temperature, and allows a single operator to perform medical procedures, enhancing the safety and efficiency of treatments like atrial fibrillation ablation.
Implementation Method 1
The pump is configured to circulate the balloon fill media along a circuit defined by the first and second conduits
Implementation Method 2
The valve assembly is configured for placement in at least a first position, a second position, and a third position
Implementation Method 3
a first conduit connected between the reservoir and the balloon for delivering the balloon fill media
Implementation Method 4
a second conduit connected between the balloon and the reservoir for returning the balloon fill media from the balloon to the reservoir
Implementation Method 5
a pump disposed along the first conduit. The pump is configured to circulate the balloon fill media along a circuit defined by the first and second conduits
Data Source
AI summary
Systems and methods for controlling fill media in a balloon catheter are disclosed. The system comprises a catheter having an inflatable balloon, a reservoir for fill media, and a first conduit for delivering fill media from the reservoir to the balloon. The system includes a second conduit for returning fill media from the balloon to the reservoir and a pump configured to circulate fill media through the conduits. The system also includes a valve assembly configured for placement in at least three positions. In the first position, fill media is delivered from the reservoir to the balloon to inflate the balloon. In the second position, fill media is drawn out of the balloon and returned to the reservoir. In the third position, fill media circulates through the conduits between the pump and the balloon and is prevented from flowing back to the reservoir.