Single-Walled Balloon Cryotherapy Error Detection
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Solution Overview
Problem
Conventional cryotherapeutic elements, such as double-walled balloons, face challenges including inconsistent thermal conductivity, bulkiness, and unsuitability for small-diameter sheaths and body lumens, which can hinder effective cryotherapy administration.
Innovation Solution
A cryotherapeutic system with a single-walled or multi-walled balloon cryotherapeutic element, equipped with enhanced error detection and response mechanisms, including rapid shutdown of refrigerant flow to minimize clinically significant refrigerant leakage in case of errors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If double-walled balloons are used for cryotherapy, then thermal insulation is improved, but thermal conductivity consistency deteriorates and device bulkiness increases
Solution Approach 1:
The patent removes the outer wall of the conventional double-walled balloon structure, retaining only the inner wall as a single-walled balloon. This extraction eliminates the thermal insulation benefits of the outer wall while simplifying the structure to achieve consistent thermal conductivity and reduced bulkiness.
Solution Approach 2:
The single-walled balloon is constructed with a thin, flexible membrane that provides consistent thermal properties. The thin film structure ensures uniform heat transfer characteristics while maintaining flexibility for navigation through body lumens and small-diameter sheaths.
2Strength
If double-walled balloons are used for cryotherapy, then structural strength is improved, but device bulkiness increases making it unsuitable for small-diameter sheaths
Solution Approach 1:
The outer wall is removed from the double-walled structure, extracting only the essential single-walled configuration. This reduces the device volume and bulkiness while the remaining single wall is engineered to provide sufficient structural strength for the application.
Solution Approach 2:
The patent modifies the wall thickness and material properties of the single-walled balloon to compensate for the removal of the outer wall. By adjusting these parameters, the single wall achieves the necessary structural strength without requiring the bulkier double-walled construction.
3Reliability
If rapid shutdown of refrigerant flow is implemented, then refrigerant leakage risk is reduced, but system complexity increases
Solution Approach 1:
The system incorporates sensors that continuously monitor the cryotherapy procedure for errors or abnormal conditions. When an error is detected, the feedback mechanism triggers an automatic rapid shutdown of refrigerant flow through electronically controlled valves, minimizing leakage risk while maintaining manageable system complexity through automated control.
Solution Approach 2:
The patent replaces manual mechanical control systems with electronic control and automation. Electronic sensors and computer-controlled valves substitute for manual operation, enabling rapid response to errors and reducing refrigerant leakage risk while the electronic control architecture manages overall system complexity.
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 addresses the limitations of conventional cryotherapeutic elements by providing precise cooling, reducing the risk of refrigerant leakage, and being suitable for use in smaller body lumens, thus enhancing the reliability and efficacy of cryotherapy treatments.
Implementation Method 1
the cryotherapeutic element can be cooled to modulate nearby nerves. The cooling caused by the cryotherapeutic element, for example, can reduce undesirable local or systemic sympathetic neural activity
Implementation Method 2
expanding refrigerant within a balloon of a cryotherapeutic element while the cryotherapeutic element is operably positioned within a body lumen
Data Source
AI summary
A method of using a cryotherapeutic system in accordance with a particular embodiment includes advancing an elongate shaft of a catheter toward a treatment location within a body lumen of a human patient and directing a flow of refrigerant toward a cryotherapeutic element at a distal end portion of the shaft. The directed refrigerant is expanded to cause cooling within a balloon of the cryotherapeutic element. The pressure within the balloon is monitored and its rate of change calculated. The rate of change is then processed using different feedback loops during different monitoring windows of a treatment cycle. The individual feedback loops include an upper and a lower threshold and are configured to cause the flow of refrigerant to the cryotherapeutic element to stop if the rate of change falls outside a range between the upper and the lower threshold.