Pass-through electrodes for impedance sensing in medical sheaths
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Solution Overview
Problem
Existing medical devices, such as sheaths and guide catheters, face challenges in incorporating impedance-based position sensors due to high costs and poor yields, primarily due to the difficulty in routing conductors through the thin walls of these devices, which leads to fractures and joint failures.
Innovation Solution
The introduction of 'pass-through' electrodes on sheaths and tubular devices, which are electrically isolated and do not require conductors, allowing for the passage of electrical signals to impedance-based 'active' electrodes, making the system electrically transparent and reducing the complexity and cost of incorporating sensors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If impedance-based position sensors are incorporated into sheaths and guide catheters, then mapping and sensing functionality is improved, but manufacturing cost and device complexity increase due to required connectors, cables, and conductor routing
Solution Approach 1:
The patent extracts the conductor routing requirement by using passive electrodes that make electrical contact through the distal end opening without requiring conductors to be routed through the thin wall. This eliminates the complex conductor integration process while maintaining sensing functionality.
Solution Approach 2:
The distal end opening serves multiple functions: it allows passage of the procedure catheter and simultaneously provides the electrical contact path for passive electrodes. This multi-functionality reduces the need for separate conductor routing paths and connectors.
2Reliability
If conductors are routed through the thin wall of the sheath to connect electrodes, then electrical connectivity is achieved, but reliability decreases due to fractures and joint failures from bending, torquing, and compression stresses
Solution Approach 1:
The patent removes conductors from the thin wall routing path entirely. Passive electrodes make contact through the distal end opening, eliminating the vulnerability of conductors embedded in the flexible wall to mechanical stresses.
Solution Approach 2:
The distal end opening acts as an intermediary structure that provides electrical contact without requiring conductors to traverse the flexible wall. This mediator approach allows electrical connectivity while avoiding the mechanical stress problem.
3Measurement precision
If sensing electrodes are incorporated into the introducer system, then position sensing capability is improved when the catheter is extended, but the electrodes become useless when the catheter is retracted into the sheath
Solution Approach 1:
The passive electrodes on the sheath serve themselves by making direct electrical contact through the distal end opening without requiring the procedure catheter to be in a specific extended position. The sensing capability is self-sustaining regardless of catheter retraction or extension status.
Solution Approach 2:
The passive electrodes provide sensing functionality in both extended and retracted configurations, making the system universally functional across different operational states. The distal end opening ensures continuous electrical contact regardless of catheter position.
Data Source
AI summary
A pass-through electrode device includes a tubular member including a proximal end, a distal end sized for introduction into a patient's body, a lumen extending between the proximal end and the distal end, and one or more pass-through electrodes on the distal end. Each pass-through electrode includes an outer portion on an outer wall of the tubular member, an inner portion exposed within an inner wall of the lumen, and is passive, e.g., electrically isolated and/or unconnected to other electrodes or components of the device. A system is also provided that includes an outer tubular member including one or more pass-through electrodes and a procedure device introducible through and deployable from the tubular member for performing a procedure, e.g., mapping and/or ablation. The procedure device includes one or more active electrodes that may be aligned with pass-through electrodes when the device is at least partially positioned within the outer member.