Support Catheter for Phrenic Nerve Pacing Stability
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Solution Overview
Problem
Current mapping catheters lack the stability and adjustable distal loop portion necessary to effectively monitor the phrenic nerve during electrophysiology procedures, particularly in the superior vena cava, where the phrenic nerve is at risk of unintended thermal damage during ablation therapies, and existing devices are not adequately sized or stiff enough to maintain contact with larger vessel diameters.
Innovation Solution
A medical support device with an elongate body that transitions between linear and expanded configurations, featuring an adjustable distal portion with actuator wires to accommodate varying vessel sizes, ensuring stable electrode contact and minimizing risk of phrenic nerve damage by allowing precise control over the catheter's diameter and configuration.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mapping catheter is used for phrenic nerve pacing, then the catheter can monitor the phrenic nerve, but the catheter shifts during the procedure resulting in loss of capture and unstable monitoring
Solution Approach 1:
The catheter is divided into distinct segments: a stiff proximal portion for stable positioning in the SVC and a compliant distal portion for conforming to the vessel wall. This segmentation allows each portion to perform its specific function optimally, resolving the contradiction between stability and ease of positioning.
Solution Approach 2:
The distal portion of the catheter is designed to be dynamically compliant, allowing it to flex and conform to the vessel wall geometry. This dynamic property enables the catheter to maintain stable contact during physiological movements while remaining easy to position.
2Reliability
If the distal portion of the catheter is expanded to contact the vessel wall, then electrode contact is improved, but the catheter becomes too large to navigate through smaller vessels
Solution Approach 1:
The catheter's distal portion transitions from a compressed low-profile state during navigation to an expanded contact state during monitoring. This dynamic size change allows the catheter to navigate small vessels when compressed and provide stable electrode contact when expanded against the vessel wall.
Solution Approach 2:
The distal contact portion is nested within the proximal delivery catheter during insertion, allowing the expanded contact elements to be delivered through a small profile sheath and then deployed at the target site for stable electrode contact.
3Reliability
If the catheter is made stiffer to maintain positioning, then catheter stability improves, but the catheter cannot conform to varying vessel diameters
Solution Approach 1:
Different portions of the catheter have different mechanical properties: the proximal portion is stiff for stable positioning, while the distal portion is compliant for conforming to various vessel diameters. This local differentiation resolves the contradiction between overall stability and local adaptability.
Solution Approach 2:
The catheter is segmented into stiff and compliant portions, each optimized for its specific function. The stiff proximal segment provides anchoring stability while the compliant distal segment adapts to vessel geometry, allowing the catheter to maintain positioning stability across varying vessel sizes.
4Productivity
If thermal ablation is applied to treat cardiac tissue, then arrhythmia conditions are treated, but the phrenic nerve may be inadvertently damaged
Solution Approach 1:
The catheter provides continuous real-time feedback by monitoring the electrogram signal from the phrenic nerve during ablation. This feedback allows the operator to detect early signs of nerve injury and adjust or stop the ablation immediately, allowing effective treatment while preventing harmful nerve damage.
Solution Approach 2:
The catheter is positioned and the phrenic nerve is identified and monitored before ablation begins. This preliminary positioning and monitoring establishes a baseline for nerve function, enabling early detection of any thermal damage during the subsequent ablation procedure.
Data Source
AI summary
A device, system, and method for providing support to a mapping catheter during mapping or pacing and for adjusting the diameter of a distal loop portion of currently available mapping catheters. A medical device support device includes an elongate body defining a wall and an at least substantially linear proximal portion and a distal portion being transitionable between an at least substantially linear configuration and an expanded configuration, the elongate body defining a lumen extending through the proximal portion and distal portion, the lumen being entirely surrounded by the wall in the proximal portion and being partially surrounded by the wall in the distal portion. For example, the lumen may be sized to receive a mapping catheter therein such that adjustment of the configuration or diameter of the distal portion of the elongate body will likewise modify the configuration or diameter of the distal portion of the mapping catheter.