Hierarchical Pulsed Waveform for Selective Tissue Ablation
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Solution Overview
Problem
Current electroporation technologies for tissue therapeutics lack selectivity and safety in delivering high DC voltage ablation therapy, particularly for cardiac arrhythmias, and require improved device designs and dosing waveforms to minimize damage to healthy tissue and reduce the need for device repositioning during procedures.
Innovation Solution
A system comprising a pulse waveform generator and an ablation device with a hierarchical pulsed waveform delivery mechanism, utilizing multiple levels of pulse sets with varying time intervals and voltage amplitudes, synchronized with cardiac pacing signals to ensure selective and rapid tissue ablation while minimizing energy and avoiding disruption of cardiac rhythms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high DC voltage is applied to tissue for electroporation ablation, then cell membrane disruption and tissue ablation are achieved, but damage to healthy tissue and safety issues occur
Solution Approach 1:
The patent segments the electroporation treatment into discrete pulse cycles with specific parameters (voltage amplitude, pulse width, inter-pulse interval). Each pulse cycle is independently controllable, allowing selective activation of electrodes and precise control of energy delivery to achieve ablation while minimizing damage to surrounding healthy tissue through spatial and temporal segmentation of the treatment protocol.
Solution Approach 2:
The patent employs dynamic adjustment of electrical parameters including voltage amplitude, pulse width, and inter-pulse interval based on tissue response and treatment stage. By modulating these parameters in real-time, the system optimizes electroporation effectiveness while reducing harmful effects, enabling adaptive control to differentiate between target tissue and healthy tissue based on their distinct electrical and mechanical properties.
2Measurement precision
If multiple electrodes are used for selective ablation, then tissue selectivity is improved, but device complexity increases
Solution Approach 1:
The multi-electrode array is segmented into independently controllable electrode groups or elements, each capable of receiving customized pulse waveforms. This segmentation enables selective activation of specific electrode regions to target precise anatomical locations while maintaining a modular architecture that manages system complexity through standardized control interfaces for each electrode segment.
Solution Approach 2:
The electrode array is designed with universal functionality where each electrode or electrode group can serve multiple purposes: ablation, mapping, and real-time monitoring. This multi-functionality reduces the need for separate devices and simplifies the overall system by allowing a single electrode structure to perform diverse tasks through programmable control of pulse delivery and signal acquisition.
3Productivity
If rapid pulse delivery is used for efficient ablation, then productivity increases, but safety risks and energy delivery control become more difficult
Solution Approach 1:
The patent implements periodic pulse delivery with carefully controlled inter-pulse intervals that allow tissue relaxation and heat dissipation between pulses. This periodic action enables rapid cumulative ablation through repeated pulse cycles while maintaining safety by preventing excessive energy accumulation in any single location, with the interval duration optimized to balance productivity with thermal and electrical safety margins.
Solution Approach 2:
The system incorporates real-time feedback mechanisms that monitor tissue response during pulse delivery, detecting parameters such as impedance changes, temperature rise, or signal characteristics that indicate approaching safety limits. Based on this feedback, the control system dynamically adjusts pulse parameters including amplitude, width, and interval to maintain safe energy delivery while maximizing ablation efficiency, thereby enabling rapid treatment without compromising safety.
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 enhances the safety and effectiveness of electroporation by reducing electric field thresholds, creating more precise ablative lesions with lower total energy delivery, thus broadening clinical applications and reducing tissue damage and arcing risks.
Implementation Method 1
Application of brief high DC voltages to tissue, which can generate locally high electric fields typically in the range of hundreds of Volts/centimeter, can disrupt cell membranes by generating pores in the cell membrane
Implementation Method 2
If the applied electric field at the membrane is larger than a threshold value, the electroporation can be irreversible and the pores remain open, permitting exchange of biomolecular material across the membrane and leading to necrosis and/or apoptosis (cell death)
Data Source
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AI summary
A system includes a pulse waveform generator and an ablation device coupled to the pulse waveform generator. The ablation device includes at least one electrode configured for ablation pulse delivery to tissue during use. The pulse waveform generator is configured to deliver voltage pulses to the ablation device in the form of a pulsed waveform. A first level of a hierarchy of the pulsed waveform includes a first set of pulses, each pulse having a pulse time duration, with a first time interval separating successive pulses. A second level of the hierarchy of the pulsed waveform includes a plurality of first sets of pulses as a second set of pulses, a second time interval separating successive first sets of pulses, the second time interval being at least three times the duration of the first time interval.