Catheter Electrode Segmentation for Safety Default Return Path
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Solution Overview
Problem
During cardiac ablation therapy, a broken wire can lead to undesirable outcomes such as shock, atrial/ventricular fibrillation, embolic formation, and unintended stimulation due to the initiation of voltage-based therapy with only one pole of the electric potential exposed.
Innovation Solution
A medical device with a catheter featuring a plurality of electrodes, including pairs with fixed polarities, and lumens with conductors to connect these electrodes, ensuring safe delivery of high voltage electroporation energy even in the event of a short circuit or broken wire.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single-pole electric potential exposure is used during therapy delivery, then the device complexity is reduced, but safety deteriorates due to risk of shock, fibrillation, and unintended stimulation
Solution Approach 1:
The catheter is segmented into multiple independent electrode elements (first electrode element, second electrode element, third electrode element, fourth electrode element) with distinct polarities. Each electrode has its own conductor pathway, allowing independent control and safe operation even if one pathway fails. This segmentation enables the system to maintain safety by isolating potential failure points while delivering therapy.
2Reliability
If multiple electrodes with independent conductors are used, then safety is improved through redundant pathways, but device complexity increases
Solution Approach 1:
Multiple electrode elements are merged into a single catheter assembly with integrated insulation and structural support. The first and second electrode elements are positioned on opposite sides of the catheter, as are the third and fourth electrode elements. This merging allows the system to achieve safety through redundancy while minimizing the increase in device complexity by consolidating multiple functions into a unified structure.
3Object-affected harmful factors
If bipolar electrode configuration is maintained during short circuit conditions, then harmful effects are prevented, but the ability to deliver energy is reduced
Solution Approach 1:
The system converts the harmful effect of a short circuit or broken wire into a beneficial safety mechanism. When a short circuit occurs in one conductor pathway, the system automatically detects the condition and prevents therapy delivery, thereby avoiding harmful effects such as shock and fibrillation. The redundant electrode configuration ensures that even if one pathway fails, the system can maintain safe operation by preventing energy delivery through the compromised pathway.
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 solution ensures safe and effective delivery of electroporation energy by maintaining bipolar operation even in the presence of a short circuit, thereby preventing harmful shocks and other adverse outcomes.
Implementation Method 1
A first lumen extends through the distal portion, the first lumen includes a first conductor configured to connect to a first electrode of the first electrode pair and a second conductor configured to connect to a second electrode of the first electrode pair
Implementation Method 2
the first electrode pair and the second electrode pair are configured to deliver high voltage electroporation energy
Data Source
AI summary
A medical device including a catheter having a proximal portion and a distal portion. A plurality of electrodes is disposed along the distal portion, the plurality of electrodes including a first electrode pair having a first fixed polarity and a second electrode pair having a second fixed polarity different than the first fixed polarity. A first lumen extends through the distal portion, the first lumen includes a first conductor configured to connect to a first electrode of the first electrode pair and a second conductor configured to connect to a second electrode of the first electrode pair. A second lumen extends through the distal portion and separated from the first lumen, the second lumen includes a third conductor configured to connect to a first electrode of the second electrode pair and a fourth conductor configured to connect to a second electrode of the second electrode pair.


