Balloon Catheter Accessory for Temperature Mapping
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Solution Overview
Problem
Current cryoablation systems face challenges in accurately assessing temperature-based lesion formation and mapping cardiac tissue due to the complexity and cost of integrating temperature sensors, as well as the inaccuracy of existing methods that do not account for tissue type and response, leading to increased procedure time and potential patient injury.
Innovation Solution
A cryoablation system and method utilizing an aftermarket, over-the-wire balloon catheter accessory equipped with temperature sensors and mapping electrodes, allowing for accurate temperature-based lesion formation assessment and mapping functionality without the need for separate devices, thereby reducing procedure complexity and cost.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If temperature sensors are integrated into the ablation device, then temperature measurement accuracy is improved, but device complexity and cost increase
Solution Approach 1:
The system divides temperature sensing functionality into a separate accessory device that attaches to the balloon catheter. The accessory contains multiple temperature sensors positioned at different locations, allowing temperature measurement without integrating sensors into the main ablation device. This segmentation resolves the contradiction by providing accurate temperature measurement while keeping the main device simple.
Solution Approach 2:
An intermediary accessory device is introduced between the operator and the balloon catheter. This accessory serves as a mediator that provides temperature sensing capability without requiring modification of the balloon catheter itself. The accessory attaches to the balloon and provides temperature data, resolving the contradiction by adding measurement capability through an intermediate component rather than integrating into the primary device.
2Measurement precision
If temperature sensors are integrated into the ablation device, then temperature measurement accuracy is improved, but device cost increases
Solution Approach 1:
The system divides temperature sensing functionality into a separate accessory device that attaches to the balloon catheter. The accessory contains multiple temperature sensors positioned at different locations, allowing temperature measurement without integrating sensors into the main ablation device. This segmentation resolves the contradiction by providing accurate temperature measurement while keeping the main device simple.
Solution Approach 2:
The temperature sensing accessory is designed as a separate, potentially disposable component rather than a permanent integration into the expensive ablation device. This approach allows the use of temperature sensors in a cost-effective manner, resolving the contradiction by providing measurement capability through a lower-cost separate component.
3Measurement precision
If separate mapping and ablation devices are used, then mapping accuracy is improved, but procedure time increases
Solution Approach 1:
The system combines mapping and ablation functionalities into a single integrated system. The balloon catheter is equipped with both mapping electrodes for electrical signal recording and ablation capability in one device. This merging resolves the contradiction by allowing both mapping and ablation to be performed with a single device, eliminating the need to switch between devices and reducing procedure time while maintaining mapping accuracy.
Solution Approach 2:
The balloon catheter is designed with multi-functionality, serving both as a mapping device and an ablation device. The catheter includes electrodes for electrical mapping and the capability to deliver ablative energy. This universality resolves the contradiction by allowing one device to perform multiple functions, eliminating the need for separate devices and reducing procedure time while maintaining mapping accuracy.
4Measurement precision
If separate mapping and ablation devices are used, then mapping accuracy is improved, but device complexity increases
Solution Approach 1:
The system combines mapping and ablation functionalities into a single integrated system. The balloon catheter is equipped with both mapping electrodes for electrical signal recording and ablation capability in one device. This merging resolves the contradiction by allowing both mapping and ablation to be performed with a single device, eliminating the need to switch between devices and reducing procedure time while maintaining mapping accuracy.
Solution Approach 2:
The balloon catheter is designed with multi-functionality, serving both as a mapping device and an ablation device. The catheter includes electrodes for electrical mapping and the capability to deliver ablative energy. This universality resolves the contradiction by allowing one device to perform multiple functions, eliminating the need for separate devices and reducing procedure time while maintaining mapping accuracy.
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 enables precise temperature-based lesion formation and mapping, reducing the number of ablations required, improving procedure accuracy, and minimizing patient risk by integrating sensing and mapping capabilities into a cost-effective catheter accessory.
Implementation Method 1
temperature sensor positioned at a distal-most portion of the sheath
Implementation Method 2
mapping electrode positioned at a distal-most portion of the sheath
Implementation Method 3
cryoablation system and device that allows for accurate temperature-based lesion formation assessment
Data Source
AI summary
A device, system and method for temperature-based lesion formation assessment and mapping functionality using an accessory usable with an over-the-wire balloon catheter. The device may include a first annular element, a plurality of wires coupled to the first annular element, and a second annular element, the plurality of wires passing from the first annular element through the second annular element and into an elongate wire conduit coupled to the second annular element. At least one of the plurality of wires may include at least one temperature sensor and/or at least one mapping electrode. The first annular element coupled to an outer surface of a sheath. As a balloon catheter is advanced out of the sheath lumen, the distal tip of the catheter engages the second annular element and pushes the wires out of the sheath lumen, everting them over the balloon of the catheter.