Ablation Catheter with Sensing Electrodes for Real-Time Lesion Control
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Solution Overview
Problem
Current ablation catheters lack real-time information on the degree of coupling between the catheter and tissue, leading to excessive energy application, which increases risks such as tissue perforation and blood coagulation during cardiac arrhythmia treatments.
Innovation Solution
A system with an ablation catheter featuring a deformable shaft, sensing electrodes, and an electronic control unit that adjusts energy delivery based on signals indicative of electrical activity and coupling, allowing for optimized mechanical and electrical coupling and real-time lesion evaluation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If clinicians apply significantly greater amounts of energy to insure an effective lesion, then the reliability of creating sufficient tissue necrosis is improved, but the risk of harmful effects such as tissue perforation, blood coagulation, and steam pops increases
Solution Approach 1:
The system employs multiple sensing electrodes positioned at different locations to continuously monitor electrical activity and impedance changes in real-time during ablation. This feedback is processed by a control system that dynamically adjusts energy delivery parameters, enabling clinicians to achieve reliable lesion creation while automatically preventing harmful effects by reducing power when tissue damage thresholds are approached.
Solution Approach 2:
The catheter performs preliminary assessments of tissue coupling and electrical properties before initiating full-power ablation. By pre-evaluating tissue characteristics and establishing baseline measurements, the system can predict optimal energy delivery parameters and avoid excessive power application that would cause tissue perforation or steam pops, thereby ensuring safe and effective lesion formation from the outset.
2Device complexity
If clinicians lack sufficient real-time information regarding the degree of coupling between the ablation catheter and tissue, then the device complexity is reduced, but the manufacturing precision of the lesion (control over energy delivery) deteriorates
Solution Approach 1:
The ablation catheter integrates multiple functions into a single device: ablation energy delivery, electrical activity sensing, impedance measurement, and coupling assessment. The sensing electrodes serve dual purposes by monitoring both electrical signals and tissue interaction characteristics. This multi-functionality provides comprehensive real-time information for precise lesion control without requiring separate diagnostic devices, thereby maintaining relative system simplicity while achieving high manufacturing precision.
3Productivity
If excessive energy is applied to create a lesion, then the productivity of the ablation procedure (speed of lesion creation) is improved, but the loss of substance (tissue damage beyond intended lesion) increases
Solution Approach 1:
The ablation process employs periodic energy delivery with intermittent pauses for reassessment. The system delivers energy in controlled bursts, then pauses to re-evaluate tissue response through sensing electrodes. This periodic approach maintains high productivity by minimizing total procedure time while preventing excessive tissue damage by allowing real-time adjustment of energy parameters based on measured tissue characteristics and lesion formation progress.
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
This approach reduces the risk of complications by ensuring precise energy application, improving the efficacy of ablation procedures and minimizing tissue damage.
Implementation Method 1
a sensing electrode disposed proximate to the ablation delivery member and configured to generate a signal responsive to electrical activity in the tissue
Implementation Method 2
The ablation catheter imparts ablative energy (e.g., radiofrequency energy, light energy, ultrasound, or thermal (cryo or heat based) energy) to the heart tissue to create a lesion
Implementation Method 3
Approximately 100 Joules of energy may be adequate to create a lesion in atrial tissue
Data Source
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AI summary
A system for diagnosis or treatment of tissue in a body is provided. The system includes an ablation catheter having a deformable, elongate shaft having proximal and distal ends. The catheter further includes an ablation delivery member disposed proximate the distal end of the shaft and configured to deliver ablation energy to ablate the tissue. In one embodiment, the ablation delivery member comprises an ablation electrode and may also be configured to generate a signal indicative of electrical activity in the tissue. The catheter further includes one or more sensing electrodes disposed proximate the ablation delivery member. The sensing electrodes are configured to generate signals indicative of electrical activity in the tissue. The system further includes an electronic control unit configured to control delivery of ablation energy from the ablation delivery member responsive to one or more of the generated signals indicative of electrical activity in the tissue.