Balloon Catheter Fluid Management with Remote Valve
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Solution Overview
Problem
Conventional balloon catheters face challenges in maintaining lower pressures required for greater tissue contact, as existing cooling systems are not compatible with these pressures, and require a lower flow rate that is inadequate for keeping the balloon and catheter components cool, while also necessitating two operators for inflation and deflation.
Innovation Solution
A balloon catheter system with a remote valve assembly that allows a single operator to control inflation and deflation, using a 'trapped volume' mode to maintain constant pressure and circulation of fill media, ensuring the balloon remains inflated and cool, with a rocker valve or sliding tube valve assembly for fluid control, and a peristaltic pump for efficient cooling and pressure management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If the balloon catheter uses lower pressure to achieve greater tissue contact, then the tissue contact quality is improved, but the cooling effectiveness deteriorates because the prior art cooling systems require higher flow rates that are incompatible with lower pressure operation
Solution Approach 1:
The system dynamically adjusts between two operational modes: a first mode for inflation/deflation at higher pressures, and a second mode for maintaining lower pressures during tissue contact. The fluid management system transitions between these modes to optimize both tissue contact quality and cooling effectiveness at different stages of the procedure.
Solution Approach 2:
The system changes the pressure parameter of the fill media over time. During inflation and deflation, higher pressures are used. During the tissue contact procedure, the pressure is reduced to lower levels while maintaining adequate cooling through controlled fill media circulation at these lower pressures.
2Ease of manufacture
If the balloon catheter uses lower pressure operation, then the tissue contact is improved, but the system complexity increases due to the need for advanced fluid management systems to maintain both low pressure and adequate cooling
Solution Approach 1:
The fluid management system is designed to perform multiple functions: inflation, deflation, cooling, and pressure maintenance. By integrating these functions into a single system with automated control, the patent reduces overall system complexity compared to having separate systems for each function.
Solution Approach 2:
The system includes automated control mechanisms that manage the fill media circulation and pressure regulation without requiring constant manual intervention. The fluid management system self-regulates to maintain appropriate pressure and cooling levels during the procedure.
3Device complexity
If conventional cooling systems are used with lower pressure balloons, then the system simplicity is maintained, but the cooling adequacy deteriorates because lower flow rates are not sufficient to keep the balloon and catheter components cool
Solution Approach 1:
The cooling system dynamically adjusts its operation based on the procedural phase. During inflation/deflation, standard cooling flow rates are used. During low-pressure tissue contact procedures, the system maintains cooling adequacy by optimizing fill media circulation at the lower pressures specific to each procedural stage.
4Productivity
If a single operator controls the balloon catheter, then the operational efficiency is improved, but the control precision deteriorates without a remote operator to manage inflation and deflation
Solution Approach 1:
The patent combines the functions of balloon manipulation and inflation/deflation control into a single integrated system under one operator. The fluid management system with its automated controls enables the single operator to precisely manage both aspects of the procedure without requiring a second operator.
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 single-operator control of balloon catheters at lower pressures, maintaining effective tissue contact and cooling the balloon and catheter components, while preventing overheating and deflation issues, thus enhancing the safety and efficiency of medical procedures.
Implementation Method 1
a peristaltic pump for efficient cooling and pressure management
Data Source
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AI summary
Systems and methods for controlling fill media in a balloon catheter are disclosed. The system can comprise 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 can also include 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.