RF Transseptal Guidewire With EGM Sensing for Aortic Avoidance
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Solution Overview
Problem
Transseptal punctures in cardiac procedures often face challenges with limited visualization, leading to potential inadvertent puncture of the aorta instead of the left atrium, and require multiple device exchanges for confirmation, which can be inefficient and risky.
Innovation Solution
A transseptal guidewire with a puncture electrode that delivers RF energy and senses intracardiac electrogram (EGM) signals to determine its location within cardiac anatomy, allowing confirmation of left atrial access without device removal or exchange, using an integrated RF energy source and electroanatomical mapping system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If traditional transseptal puncture techniques are used without integrated sensing, then the procedure can be performed with standard equipment, but the ability to confirm left atrial access and distinguish from aortic puncture is limited
Solution Approach 1:
The patent combines RF energy delivery capability and EGM sensing functionality into a single guidewire device. The guidewire includes both an RF electrode for delivering radiofrequency energy to puncture tissue and EGM electrodes for sensing intracardiac electrical signals, merging two previously separate functions into one integrated device that enables both puncture and anatomical location confirmation.
Solution Approach 2:
The guidewire is designed with multi-functionality to serve multiple purposes: it can deliver RF energy for transseptal puncture, sense EGM signals for anatomical identification, and potentially guide catheter delivery. This universal design allows a single device to perform multiple critical functions in the transseptal procedure, reducing the need for multiple separate devices.
2Reliability
If multiple device exchanges are performed for confirmation, then anatomical location can be verified, but procedural time and risk increase
Solution Approach 1:
The system performs anatomical location identification and puncture confirmation actions during the initial guidewire placement and RF delivery phase, rather than requiring subsequent device exchanges for verification. By integrating EGM sensing with the initial puncture procedure, the system completes confirmation actions preliminarily, eliminating the need for time-consuming follow-up device exchanges.
3Object-affected harmful factors
If RF energy is delivered without EGM sensing capability, then the puncture can be performed, but the risk of inadvertent aortic puncture cannot be mitigated
Solution Approach 1:
The system continuously monitors EGM signals during RF energy delivery and provides real-time feedback about the electrode's anatomical location. The controller analyzes the EGM characteristics to determine whether the RF electrode is in contact with left atrial tissue or aortic tissue, allowing the operator to adjust or terminate the procedure if aortic puncture is detected, thus mitigating harmful effects through feedback control.
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 transseptal puncture confirmation, reducing the risk of aortic puncture and minimizing procedural inefficiencies by integrating RF energy delivery and EGM sensing in a single guidewire, enhancing procedural safety and efficiency.
Implementation Method 1
Electrical energy can be applied to the electrodes either as a train of high frequency pulses or as a continuous signal typically in the radiofrequency (RF) range to perform the puncturing techniques
Implementation Method 2
Tissue that contacts the plasma experiences a rapid vaporization of cellular fluid to produce a puncturing effect
Implementation Method 3
Electrosurgical devices pass electrical energy through tissue between the electrodes to puncture tissue with plasma formed on the energized electrode
Implementation Method 4
receive an intracardiac electrogram (EGM) reading signal from the crossing member electrode, compare the EGM reading signal to at least one of aortic EGM characteristics having information to identify EGM signals emanating from the aorta and left atrial EGM characteristics having information to identify EGM signals emanating from the left atrium
Data Source
AI summary
A transseptal surgical system to puncture an atrial septum within a heart includes an electrosurgical crossing assembly and a controller coupled to the crossing assembly. The crossing assembly includes a crossing member coupled to a radiofrequency (RF) energy source. The crossing member includes a crossing member distal tip having a crossing member electrode to deliver the RF energy. The controller can receive an intracardiac electrogram (EGM) reading signal from the crossing member electrode, compare the EGM reading signal to at least one of aortic EGM characteristics having information to identify EGM signals emanating from the aorta and left atrial EGM characteristics having information to identify EGM signals emanating from the left atrium to determine a location of the crossing member electrode within cardiac anatomy, and generate an alert if the crossing member electrode is determined to be within the aorta.