Medical Electrical Lead Electrode Assembly with Insulative Carrier
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Solution Overview
Problem
Current medical electrical lead electrode assemblies face challenges in efficiently manufacturing configurations that allow electrodes to make contact with target stimulation sites, support joints between electrodes and conductors, and electrically isolate them, while improving operational efficiency.
Innovation Solution
The development of a medical electrical lead with an insulative paddle-shaped body supporting an array of electrodes, where conductors are routed through pre-formed channels within an elongate tubular body, and electrodes are coupled to contacts via tabs and projections, allowing independent powering and electrical isolation, with an insulative carrier formed from flexible polymer and a mesh panel for structural integrity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrodes are mounted on a distal portion of the lead body to make contact with target stimulation sites, then the lead can provide effective electrical stimulation, but the manufacturing complexity increases due to the need to support multiple electrodes and conductors with proper isolation
Solution Approach 1:
The lead body is segmented into distinct functional zones: a proximal portion for conductor routing and a distal portion for electrode mounting. This segmentation allows independent optimization of each section, simplifying the overall assembly process while maintaining effective electrical stimulation capability.
Solution Approach 2:
An insulative coating is applied to portions of the lead body to act as an intermediary that provides electrical isolation between conductors and electrodes. This mediator enables safe mounting of multiple electrodes without complex isolation structures, reducing assembly complexity while ensuring effective stimulation.
2Adaptability or versatility
If multiple electrodes are mounted on the lead body to provide flexible stimulation patterns, then the adaptability improves, but the manufacturing time and complexity increase
Solution Approach 1:
The insulative coating is applied to the lead body before electrode mounting, performing the isolation function in advance. This preliminary action eliminates the need for complex isolation structures during assembly, significantly improving manufacturing efficiency while allowing multiple electrodes to be mounted for flexible stimulation patterns.
Solution Approach 2:
The insulative coating serves multiple functions simultaneously: electrical isolation between conductors and electrodes, mechanical support for electrode mounting, and structural integrity for the lead body. This multi-functionality reduces the number of separate components needed, improving manufacturing efficiency while enabling versatile electrode configurations.
3Stability of the object's composition
If the lead body is configured to support joints between electrodes and conductors, then the structural integrity improves, but the manufacturing complexity increases
Solution Approach 1:
The insulative coating on the lead body provides self-service by automatically providing mechanical support and electrical isolation at the joints between electrodes and conductors. This eliminates the need for separate support structures or complex assembly procedures, maintaining structural integrity while simplifying the manufacturing process.
4Reliability
If conductors are routed through pre-formed channels in the lead body, then the electrical isolation improves, but the manufacturing precision requirements increase
Solution Approach 1:
The insulative coating is applied to the lead body before conductor routing, establishing the isolation framework in advance. This preliminary action reduces the precision requirements for subsequent channel formation and conductor placement, as the coating already provides the necessary isolation boundaries.
Solution Approach 2:
The insulative coating changes the electrical parameters of the lead body by providing a high-resistance barrier between conductors and electrodes. This parameter change enables relaxed mechanical tolerances for channel formation, as the coating compensates for minor positioning variations and maintains effective electrical isolation.
Data Source
AI summary
A method for making a medical electrical lead electrode assembly includes the steps of: forming an insulative carrier from an insulative material; coupling at least one conductive component to the carrier by inserting at least one tab of the at least one conductive component through the carrier, the tab extending away from an electrode portion of the component such that, after the tab is inserted, the electrode portion is disposed on a first side of the carrier and the tab is disposed on a second side of the carrier; coupling an elongate flexible conductor to the tab of the at least one component; and forming an insulative layer over the tab and the conductor on the second side of the carrier.