Implantable Lead Flag Extensions for Manufacturing Precision
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Solution Overview
Problem
The manual assembly of neurostimulating device implantable leads is laborious, requires skilled technicians, and results in variations in wire spacing and organization, leading to undesired geometry and property variations within and between devices, while also being a low-yield and low-throughput process.
Innovation Solution
The use of flag extensions on a circuit substrate, which are formed during the manufacturing process to facilitate alignment, mechanical overlocking, and anchoring, allowing for efficient production of implantable leads with improved geometry and properties, including thermoforming and liquid injection molding techniques to create a flexible body that encapsulates the circuit.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If manual assembly is used to construct implantable leads, then skilled technicians can handle the wires, but the process is laborious and results in significant variation in wire spacing and organization
Solution Approach 1:
The lead construction is divided into modular components: a circuit substrate with pre-formed conductive traces and separate flag extensions. This segmentation allows automated formation of components that are later assembled together, eliminating manual wire handling while maintaining precise spacing through the structured substrate design.
Solution Approach 2:
The conductive traces and flag extensions are pre-formed on the circuit substrate using automated manufacturing processes before final assembly. This preliminary action establishes precise wire spacing and organization in advance, eliminating variation introduced during manual assembly while enabling higher throughput production.
2Productivity
If manual assembly is used to construct implantable leads, then wires can be handled flexibly, but the process is expensive due to low yield and low throughput
Solution Approach 1:
The circuit substrate design incorporates self-aligning features and pre-positioned conductive traces that automatically ensure correct wire spacing and organization during assembly. This self-service approach reduces the need for skilled manual intervention, enabling automated manufacturing processes that increase throughput while maintaining consistency and reducing costs.
3Manufacturing precision
If flag extensions are formed during manufacturing, then alignment and mechanical overlocking are facilitated, but the manufacturing process becomes more complex
Solution Approach 1:
The flag extensions are merged with the circuit substrate as integral components formed during the same manufacturing process. This combination eliminates the need for separate alignment and attachment operations, as the flags are already precisely positioned on the substrate. The integrated design simplifies the overall manufacturing process while maintaining high alignment precision through automated formation of both the substrate and flags together.
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
This method reduces manual handling and variation, increases production efficiency, and results in implantable leads with consistent geometry and properties, improving the manufacturing yield and throughput while maintaining biocompatibility and functionality.
Implementation Method 1
thermoforming and liquid injection molding techniques to create a flexible body that encapsulates the circuit
Implementation Method 2
thermoforming and liquid injection molding techniques to create a flexible body that encapsulates the circuit
Data Source
AI summary
In one example, an implantable lead includes a substrate and an electrically conductive material disposed on the substrate to form a flexible circuit. The flexible circuit includes a proximal end adapted to electrically connect to an implantable processor, a distal portion adapted to stimulate a cochlear nerve, and a lead body extending from the proximal end to the distal portion, the lead body having a longitudinal axis and comprising a plurality of electrical traces adapted to carry electrical signals from the proximal end to the distal portion. A flag extension is formed in the substrate and extends laterally outward from the lead body longitudinal axis. A method for forming a cochlear lead with a flag extension is also provided.