Cryogenic Balloon Catheter Sensor Placement
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Solution Overview
Problem
Current cryoablation devices for treating cardiac arrhythmias face challenges in delivering therapeutic ablative energy effectively while minimizing collateral tissue injury and integrating real-time physiological monitoring, with existing solutions often resulting in bulkier devices and electrode detachment issues during expansion and contraction.
Innovation Solution
A cryogenic balloon catheter system with a first inflatable balloon and electrodes positioned away from its maximum circumference, coupled with flex circuits and reference electrodes, allows for real-time physiological parameter sensing and controlled energy delivery, enabling seamless integration of sensing and ablative functions without compromising the device's therapeutic efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional sensors are added to the balloon for real-time physiological monitoring, then measurement precision is improved, but device complexity and bulk increase necessitating a larger delivery sheath
Solution Approach 1:
The patent combines multiple sensing functions (temperature, pressure, electrical activity) into a single integrated sensor assembly that is incorporated within the balloon structure itself, rather than adding separate external sensors. This integration reduces overall device bulk while maintaining comprehensive real-time monitoring capabilities.
Solution Approach 2:
The sensor assembly is nested within the balloon wall structure, with sensors positioned in concentric layers or embedded within the balloon material. This nesting approach minimizes the external profile of the device while housing multiple sensing elements, allowing passage through smaller delivery sheaths.
2Measurement precision
If electrodes are positioned on the maximum circumference of the inflated balloon for optimal sensing, then measurement precision is improved, but reliability deteriorates due to electrode detachment during expansion and contraction
Solution Approach 1:
The patent positions electrodes at specific locations away from the maximum circumference region of the inflated balloon, where radial expansion forces are minimized. This selective positioning maintains adequate sensing capability while avoiding the high-stress zone that causes detachment, thereby improving reliability during balloon inflation/deflation cycles.
Solution Approach 2:
Instead of positioning electrodes solely based on circumferential optimization, the patent considers the three-dimensional stress distribution across the balloon surface during inflation. By selecting positions that optimize the balance between sensing accuracy and mechanical stability in 3D space, the electrodes remain securely attached while maintaining functional performance.
3Productivity
If therapeutic ablative energy is increased to ensure complete tissue necrosis, then treatment efficacy is improved, but object-generated harmful factors worsen due to collateral tissue injury
Solution Approach 1:
The patent incorporates real-time physiological sensors that continuously monitor tissue temperature, pressure, and electrical activity during the ablation process. This feedback is used to dynamically adjust the delivered energy levels, ensuring sufficient tissue necrosis while automatically reducing energy when approaching thresholds that could cause collateral damage to surrounding structures.
Solution Approach 2:
The patent delivers energy in controlled partial doses rather than maximum continuous energy, using multiple lower-energy pulses with monitoring intervals. This approach achieves cumulative tissue necrosis equivalent to higher single-dose energy while providing repeated opportunities to detect and prevent collateral tissue injury between pulses.
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 provides precise and controlled ablative energy delivery, reducing collateral tissue injury and enhancing therapeutic outcomes by integrating sensors and energy delivery mechanisms within a compact, stable device that maintains functionality across inflation and deflation states.
Implementation Method 1
The energy delivery component of the system is typically at or near the most distal (furthest from the operator) portion of the catheter, and often at a tip of the device. Various forms of energy are used to ablate diseased heart tissue.
Implementation Method 2
Recently, the use of techniques known as 'balloon cryotherapy' catheter procedures to treat AF have increased.
Implementation Method 3
The plurality of electrodes can sense a physiological parameter within the body.
Data Source
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AI summary
An intravascular catheter system for treating a condition in a body includes a catheter shaft, a first inflatable balloon and a plurality of electrodes. The first inflatable balloon is positioned near a distal end of the catheter shaft. The first inflatable balloon moves between an inflated state and a substantially deflated state. In the inflated state, the first inflatable balloon has a maximum circumference. The plurality of electrodes are attached to the first inflatable balloon away from the maximum circumference of the first inflatable balloon. In some embodiments, the plurality of electrodes are attached to the inner surface of the first inflatable balloon. In various embodiments, the intravascular catheter system can also include two or more flex circuits that substantially face one another when the first inflatable balloon is in the substantially deflated state.