Endocardial Ablation Catheter with Segmented Electrodes
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Solution Overview
Problem
There is a need for thin, flexible, and atraumatic devices that can effectively deliver high DC voltage electroporation ablation therapy selectively to endocardial tissue while minimizing damage to healthy tissue.
Innovation Solution
The development of a system comprising a signal generator and an ablation device with a set of splines, each equipped with jointly wired or independently addressable electrodes, configured to deliver pulse waveforms to tissue, allowing for selective and controlled electroporation of endocardial tissue through reversible or irreversible mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high DC voltage is applied to deliver electroporation ablation therapy, then ablation effectiveness is improved, but damage to healthy tissue increases
Solution Approach 1:
The patent applies different properties to different parts of the device: the distal portion has electrodes for delivering high voltage pulses to create localized ablation zones, while the proximal portion has lower voltage electrodes for sensing and pacing. This local differentiation allows effective ablation at the target site while minimizing damage to surrounding healthy tissue through controlled voltage distribution.
Solution Approach 2:
The catheter is divided into multiple segmented electrodes along its length, with each electrode independently controllable. This segmentation allows selective application of high voltage to specific segments for ablation while keeping other segments at lower voltages, thereby achieving precise spatial control over where tissue damage occurs and protecting healthy areas.
2Ease of operation
If thin and flexible device structure is used, then ease of delivery and patient comfort are improved, but structural strength and electrical insulation may be compromised
Solution Approach 1:
The catheter employs a flexible shaft with thin-walled construction that can be advanced through blood vessels to the heart. The flexibility allows navigation through complex anatomy, while the shaft maintains sufficient mechanical strength through its design. Thin film insulation layers are applied to electrical conductors within the shaft to provide electrical isolation while maintaining overall device thinness.
Solution Approach 2:
The catheter construction utilizes composite materials combining flexible polymers for the shaft with embedded metal conductors and insulating layers. This composite structure achieves the necessary balance between flexibility for delivery and mechanical/electrical strength for safe operation. The multi-layer construction provides both structural integrity and electrical insulation in a thin profile.
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 and efficient ablation of tissue with reduced damage to healthy tissue by generating controlled electric fields, enhancing the safety and effectiveness of electroporation therapy.
Implementation Method 1
Application of brief high DC voltages to tissue may generate locally high electric fields typically in the range of hundreds of volts per centimeter that disrupt cell membranes by generating pores in the cell membrane. This electroporation may be irreversible if the applied electric field at the membrane is larger than a threshold value
Data Source
AI summary
Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a pulse waveform signal generator for medical ablation therapy, and an endocardial ablation device includes at least one electrode for ablation pulse delivery to tissue. The signal generator may deliver voltage pulses to the ablation device in the form of a pulse waveform. The system may include a cardiac stimulator for generation of pacing signals and for sequenced delivery of pulse waveforms in synchrony with the pacing signal.