Spline Electrode Catheter for PFA Ablation and Cardiac Mapping
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Solution Overview
Problem
Existing ablation techniques like RF and cryoablation indiscriminately damage healthy tissue, while irreversible electroporation can selectively target tissue but lacks effective mapping and sensing capabilities.
Innovation Solution
A catheter with splines that transition between configurations, featuring electrodes and flexible circuits for both ablation and sensing, allowing precise electroporation and electroanatomical mapping.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If thermal ablation techniques (RF or cryoablation) are used to destroy tissue, then tissue ablation is achieved, but healthy tissue is indiscriminately damaged or killed
Solution Approach 1:
The patent applies local quality by using multiple electrodes arranged in specific patterns (e.g., triangular, square) to create localized electric fields that target specific tissue regions. The electric field strength and duration are optimized to achieve selective ablation of targeted tissue while sparing surrounding healthy tissue, thereby resolving the contradiction between achieving reliable ablation and minimizing collateral damage.
2Reliability
If irreversible electroporation is used to selectively kill targeted tissue, then selectivity is improved, but mapping and sensing capabilities are lacking
Solution Approach 1:
The patent implements multi-functionality by integrating multiple electrode types into a single catheter assembly. The catheter includes ablation electrodes for irreversible electroporation, sensing electrodes for detecting physiological signals, and mapping electrodes for electroanatomical mapping. This universal design enables the device to perform ablation, sensing, and mapping functions simultaneously, resolving the contradiction between selectivity and versatility.
Solution Approach 2:
The patent merges ablation, sensing, and mapping capabilities into a single integrated catheter system. The electrode assembly combines multiple functions in one device, allowing simultaneous performance of targeted tissue ablation via irreversible electroporation and cardiac mapping via electroanatomical mapping, thereby eliminating the need for separate devices and improving overall versatility.
3Adaptability or versatility
If a catheter with multiple electrodes for both ablation and sensing is designed, then versatility is improved, but device complexity increases
Solution Approach 1:
The patent applies segmentation by dividing the electrode assembly into distinct functional groups (ablation electrodes, sensing electrodes, mapping electrodes) with specific spatial arrangements. Each segment serves its dedicated function, and the modular design simplifies the overall system architecture. The flexible circuit is also segmented into separate trace paths for different electrode types, making the complex multi-functional device manageable and manufacturable.
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 targeted tissue ablation with minimal collateral damage and accurate mapping of cardiac tissue, enhancing therapeutic efficacy.
Implementation Method 1
In electroporation, or electro-permeabilization, an electrical field is applied to cells to increase the permeability of the cell membrane. The electroporation can be reversible or irreversible, depending on the strength of the electric field.
Implementation Method 2
In irreversible electroporation, trains of short, high voltage pulses are used to generate electric fields that are strong enough to kill cells through apoptosis.
Implementation Method 3
In RF ablation, a probe is inserted into the patient and radio frequency waves are transmitted through the probe to the surrounding tissue. The radio frequency waves generate heat, which destroys surrounding tissue and cauterizes blood vessels.
Implementation Method 4
In cryoablation, a hollow needle or cryoprobe is inserted into the patient and cold, thermally conductive fluid is circulated through the probe to freeze and kill the surrounding tissue.
Data Source
AI summary
A catheter for ablating cardiac tissue through irreversible electroporation is disclosed. The catheter includes an elongated shaft having a distal region, the elongated shaft defining a longitudinal axis. A set of splines extend from the distal region of the shaft for translation along the longitudinal axis to transition between a collapsed configuration and an expanded configuration. Each spline forms a loop in the expanded configuration. Each spline of the set of splines includes an electrode assembly having a flexible circuit. The flexible circuit includes lead traces electrically coupled to electrodes on a surface of each of the respective splines.


