Balloon Catheter Fluid Management for Low-Pressure Cooling
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Solution Overview
Problem
Conventional balloon catheters face challenges in maintaining lower inflation pressures, which are necessary for greater tissue contact, due to inadequate cooling and requiring multiple operators for inflation and deflation.
Innovation Solution
A balloon catheter system with a fluid management system that includes a reservoir, conduits, and a pump to circulate fill media, allowing for controllable inflation and deflation at pressures between 0.2 and 1 psi, while maintaining balloon and catheter component cooling, and enabling single-operator control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If lower inflation pressure is used to achieve greater tissue contact, then tissue contact improvement is achieved, but cooling capability deteriorates due to insufficient flow rate
Solution Approach 1:
The system dynamically adjusts the peristaltic pump speed to maintain adequate cooling flow rate even at lower balloon inflation pressures. The pump speed can be varied independently of balloon pressure, allowing the operator to optimize both tissue contact (low pressure) and cooling (adequate flow rate) simultaneously through dynamic parameter adjustment.
2Reliability
If separate remote operator is used to inflate/deflate balloon, then inflation control is achieved, but operator complexity increases requiring at least two operators
Solution Approach 1:
The system merges the balloon inflation/deflation control function with the primary operator's capabilities by providing direct manual control of the peristaltic pump that drives fill media through the balloon. This integration allows one operator to simultaneously perform both manipulation and inflation control functions that previously required separate operators.
Solution Approach 2:
The peristaltic pump system allows the operator to directly control balloon inflation and deflation through self-contained manual operation of the pump mechanism, eliminating the need for a separate remote operator. The system serves itself by providing direct mechanical control of fill media flow without requiring additional personnel or complex remote control systems.
3Device complexity
If conventional cooling system is used with lower PSI balloons, then system simplicity is maintained, but cooling effectiveness deteriorates due to lower flow rate requirement
Solution Approach 1:
The peristaltic pump provides dynamic control over fill media flow rate, allowing the system to maintain adequate cooling flow even when balloon inflation pressure is reduced. The pump speed can be adjusted independently to ensure sufficient cooling performance regardless of the balloon's inflation state, resolving the conflict between system simplicity and cooling effectiveness.
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 effectively maintains balloon catheters at lower pressures, ensuring tissue safety and allowing single-operator procedures by creating a pressure differential using a vacuum conduit and peristaltic pump, enhancing cooling efficiency and operational simplicity.
Implementation Method 1
A pump is disposed along the first conduit and configured to circulate the balloon fill media along a circuit defined by the first and second conduits
Implementation Method 2
A vacuum conduit is in fluid communication with the reservoir and is acted upon by the pump to create negative pressure within the vacuum conduit which in turn results in a pressure drop within the reservoir and creation of a pressure differential along the circuit
Implementation Method 3
the balloon fill media is circulated into and out of the balloon to keep the balloon temperature cool such that it does not damage the tissue of the patient
Data Source
AI summary
A method for maintaining a balloon of a balloon catheter at a prescribed pressure of between about 0.2 psi and 1 psi comprises the step of: generating a vacuum within a reservoir defined in a burette that is part of a fluid management system that is configured to controllably inflating and deflating the balloon by circulating balloon fill media along a fluid circuit, wherein generating the vacuum results in formation of a pressure differential along the fluid circuit, thereby allowing the balloon to be maintained at the prescribed pressure between about 0.2 psi and about 1 psi.