RF PFO Closure Catheter with Impedance and Temperature Feedback
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Conventional methods for closing patent foramen ovale (PFO) using radio frequency (RF) energy are inefficient, often requiring invasive procedures and failing to achieve satisfactory closure, leading to additional medical interventions.
Innovation Solution
A medical system and device that includes a catheter with expandable portions and anchors, equipped with thermocouples and impedance electrodes to measure tissue characteristics, allowing for precise determination and application of RF energy for effective PFO closure, utilizing RF energy to weld tissue together and stimulate growth.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional RF energy methods are used for PFO closure, then the procedure can be performed with standard equipment, but the closure effectiveness is insufficient and additional interventions are required
Solution Approach 1:
The patent applies preliminary action by measuring tissue characteristics (impedance, temperature) before RF energy application to determine the optimal RF dosage in advance. This pre-assessment allows the system to calculate and prepare the precise energy parameters needed, ensuring effective closure on the first attempt and avoiding the need for additional interventions.
Solution Approach 2:
The patent implements feedback by continuously monitoring tissue characteristics during RF energy application and using this information to adjust the RF dosage in real-time. The system measures impedance and temperature changes, compares them against target values, and modifies the energy delivery accordingly to achieve complete PFO closure while preventing tissue damage.
2Reliability
If higher RF energy is applied to ensure PFO closure, then closure effectiveness improves, but the risk of tissue damage increases
Solution Approach 1:
The patent uses feedback by continuously monitoring tissue temperature and impedance during RF energy application. The system compares real-time measurements against predetermined safety thresholds and automatically adjusts or terminates energy delivery when limits are approached, ensuring effective closure while preventing thermal damage to surrounding tissues.
Solution Approach 2:
The patent applies parameter changes by dynamically adjusting RF energy parameters (power, duration, frequency) based on real-time tissue characteristics. The system modifies these parameters during the procedure to optimize closure effectiveness while maintaining tissue safety, transitioning from fixed-dose protocols to adaptive dose delivery.
3Measurement precision
If precise tissue measurement devices are added to determine RF dosage, then RF energy application accuracy improves, but device complexity increases
Solution Approach 1:
The patent merges multiple functions into the catheter assembly by integrating temperature sensors, impedance electrodes, and RF energy delivery elements into a single unified device. This combination eliminates the need for separate measurement and treatment instruments, reducing procedural complexity while maintaining high measurement precision for determining RF dosage.
Solution Approach 2:
The patent applies universality by designing the catheter to perform multiple functions: tissue characterization through impedance measurement, temperature monitoring, RF energy delivery, and real-time dosage calculation. This multi-functional approach consolidates what would traditionally require multiple separate devices into one universal tool, improving measurement accuracy without proportionally increasing 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 enables effective closure of PFO by accurately determining and applying RF energy, reducing the need for invasive procedures and improving the success rate of tissue welding, thereby minimizing additional medical interventions.
Implementation Method 1
The medical device can include other devices, such as a thermocouple, for use in measuring a tissue characteristic
Implementation Method 2
The medical device can include other devices, such as an impedance electrode, for use in measuring a tissue characteristic
Implementation Method 3
A PFO can be treated by being closed by a surgical procedure. Additionally, other similar defects (e.g., septal or otherwise) where some tissue needs to be closed in order to function properly
Implementation Method 4
utilizing RF energy to weld tissue together and stimulate growth
Data Source
AI summary
A medical system and device for use in delivering RF energy to a tissue opening and a method for determining an RF dose is disclosed. In one embodiment, the medical device includes an electrode or anchor and one or more devices, such as an impedance electrode, RF electrode and/or thermocouple. The electrode or anchor can be deployed from a delivery shaft inside the left atrium, for example, of a heart and substantially conform to the tissue proximate the tissue opening. Tissue characteristics, such as temperature and/or impedance, can be measured, before, during and after application of RF energy to the tissue, by one or more devices to determine an RF dose. After energy is applied to the tissue between the left and right electrodes, the left electrode can be removed from the left atrium by being received back into the delivery shaft and the delivery shaft thereafter removed from the opening.