Cryoablation Balloon Catheter with Pressure Sensor for Occlusion Detection
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Solution Overview
Problem
Current cryoablation procedures for treating cardiac arrhythmias, such as atrial fibrillation, face challenges in determining optimal pulmonary vein occlusion, which is crucial for effective ablation, often relying on contrast agents or fluoroscopy, and lack real-time pressure feedback for ensuring complete circumferential contact and heat transfer.
Innovation Solution
A cryogenic balloon catheter system equipped with a pressure sensor and control system that inflates the balloon, displays pressure waveforms, and determines occlusion based on changes in the pressure waveform, allowing for real-time monitoring and confirmation of pulmonary vein occlusion during the procedure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If contrast agents or fluoroscopy are used to determine pulmonary vein occlusion, then occlusion detection is possible, but procedure time increases and patient exposure to radiation occurs
Solution Approach 1:
The patent replaces mechanical/optical imaging systems (fluoroscopy and contrast agents) with a pressure sensing system that uses fluid pressure measurements to detect pulmonary vein occlusion. The pressure sensor monitors pressure changes within the balloon to determine occlusion status, eliminating the need for radiation-based imaging and reducing procedure time.
Solution Approach 2:
The patent implements real-time feedback by continuously monitoring pressure waveform changes during balloon inflation and ablation. The system provides immediate feedback on occlusion status through pressure measurements, allowing operators to adjust the procedure dynamically without waiting for post-procedure imaging confirmation.
2Measurement precision
If contrast agents or fluoroscopy are used to determine pulmonary vein occlusion, then occlusion detection is possible, but patient radiation exposure increases
Solution Approach 1:
The patent replaces radiation-based detection methods (fluoroscopy and contrast agents) with a mechanical pressure sensing system. The pressure sensor measures pressure changes within the balloon to detect occlusion, providing an alternative that eliminates ionizing radiation exposure while maintaining occlusion detection capability.
3Measurement precision
If real-time pressure monitoring is implemented, then occlusion confirmation accuracy improves, but device complexity increases
Solution Approach 1:
The patent makes the pressure sensor serve multiple functions: it monitors balloon inflation pressure, detects pulmonary vein occlusion through pressure waveform analysis, and provides real-time feedback on ablation effectiveness. This multi-functionality reduces the need for separate detection systems and minimizes overall device complexity while improving measurement precision.
4Productivity
If pressure sensor is integrated into the balloon catheter, then real-time feedback is achieved, but manufacturing complexity increases
Solution Approach 1:
The patent merges the pressure sensor directly into the balloon catheter structure, integrating the sensing element with the existing catheter components. This integration allows real-time pressure monitoring during the procedure while utilizing the existing catheter manufacturing processes, thereby minimizing the impact on manufacturing complexity despite the added functionality.
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 and efficient occlusion confirmation, reducing procedure time and improving outcomes by providing real-time pressure feedback, thereby ensuring effective ablation and minimizing tissue damage.
Implementation Method 1
a pressure sensor coupled to the balloon catheter at a location distal to the expandable balloon... detect and display on the graphical display a pressure waveform sensed by the pressure sensor
Implementation Method 2
one or more cryogenic balloons are placed in the left atrium and positioned against the ostium of the pulmonary vein to occlude blood flow from the pulmonary veins into the left atrium
Implementation Method 3
a cryogenic fluid (e.g., nitrous oxide) is delivered under pressure to an interior of the one or more cryogenic balloons. The cryogenic fluid causes necrosis of the targeted tissue
Data Source
AI summary
A cryogenic balloon catheter system for treating a condition in a patient includes a balloon catheter including a shaft, an expandable balloon attached to a distal portion of the shaft, and a pressure sensor coupled to the balloon catheter at a location distal to the expandable balloon. The system further includes a pump coupled to and configured to inflate the expandable balloon with a fluid, a graphical display configured to display a complication of data relating to the balloon catheter and a control system adapted to selectively inflate the expandable balloon and detect and display on the graphical display a pressure waveform sensed by the pressure sensor.