Catheter Spline Electrodes for Selective Electroporation
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Solution Overview
Problem
There is a need for thin, flexible, and atraumatic devices that can selectively deliver high DC voltage electroporation ablation therapy to endocardial tissue while minimizing damage to healthy tissue, as existing methods lack effective means for precise and selective application of pulsed electric fields.
Innovation Solution
The development of a system comprising a catheter with a set of splines, each equipped with electrodes that can transition between configurations to deliver pulse waveforms to tissue, allowing for selective and rapid application of high electric fields to specific regions, reducing unnecessary tissue damage and electrical arcing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high DC voltage electroporation ablation therapy is applied to endocardial tissue, then tissue ablation effectiveness is improved, but damage to healthy tissue increases
Solution Approach 1:
The ablation device is divided into multiple splines (e.g., 6 splines) with electrodes distributed along each spline. This segmentation allows selective activation of specific electrode pairs targeting only the intended tissue region while leaving surrounding healthy tissue unaffected. The segmented structure enables precise spatial control of the electric field distribution.
Solution Approach 2:
The device creates highly localized electric fields between specific electrode pairs (e.g., distal electrode and cap electrode) with precise geometric configuration. The electric field is concentrated in the immediate vicinity of the electrodes (within 3mm separation) while rapidly decaying with distance, providing local ablation effect without affecting distant healthy tissue. This local quality is achieved through controlled electrode geometry and spacing.
2Manufacturing precision
If pulsed electric fields are applied to achieve selective ablation, then precision of tissue targeting is improved, but device complexity increases
Solution Approach 1:
The splines are designed to be flexible and configurable, allowing the device to adapt its shape to conform to the endocardial surface geometry. The splines can be positioned and oriented dynamically to achieve optimal electrode-tissue contact and precise targeting. This dynamic configurability enables accurate tissue targeting without requiring overly complex rigid structures.
Solution Approach 2:
The same spline structure serves multiple functions: it provides mechanical support, enables flexible positioning, and carries the electrodes for electric field delivery. The electrodes themselves can be configured in different patterns (distal, proximal, intermediate) to treat different tissue regions. This multi-functionality reduces the need for separate specialized components, simplifying the overall device while maintaining precision.
3Reliability
If high electric fields are delivered to ablate tissue, then ablation efficacy is improved, but energy consumption increases
Solution Approach 1:
The ablation is achieved through delivery of pulsed electric fields rather than continuous high-voltage application. The pulsed waveform delivers high electric field intensity during brief pulses to achieve irreversible electroporation, followed by intervals where no energy is delivered. This periodic action maintains high ablation efficacy while significantly reducing average energy consumption compared to continuous delivery.
Solution Approach 2:
The electric field energy is highly concentrated between specific electrode pairs with precise geometric configuration (3mm separation). This localized energy delivery achieves effective ablation of target tissue with minimal energy required, as the energy is focused exactly where needed rather than distributed over a large area. The local quality of energy delivery improves efficacy while reducing total energy consumption.
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 enables precise and effective tissue ablation with reduced energy delivery and minimized damage to healthy tissue, enhancing the safety and efficiency of electroporation therapy for cardiac arrhythmias such as atrial fibrillation.
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 such that the pores do not close and remain open, thereby permitting exchange of biomolecular material across the membrane leading to necrosis and/or apoptosis (cell death).
Data Source
AI summary
Systems, devices, and methods for electroporation ablation therapy are disclosed, with the device including a set of splines coupled to a catheter for medical ablation therapy. Each spline of the set of splines may include a set of electrodes formed on that spline. The set of splines may be configured for translation to transition between a first configuration and a second configuration.