Tapered Peripheral Nerve Stimulation Electrode with Integrated Anchors
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Solution Overview
Problem
Current epidural electrodes designed for neuromodulation are fragile and prone to fracture when used in subcutaneous locations, and require separate anchor systems that complicate implantation and can cause electrode migration, leading to technical performance issues and complications such as infection and skin erosion.
Innovation Solution
A tapered and flexible electrode lead with integrated anchors and a thicker lead body, designed specifically for subcutaneous placement over peripheral nerves, featuring a peel-away sheath introducer for secure implantation and reduced migration risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If epidural electrodes are used off-label for subcutaneous placement, then neuromodulation can be achieved, but the electrodes are prone to fracture and skin erosion
Solution Approach 1:
The electrode lead features a tapered design where the distal portion (at the nerve stimulation site) has a smaller diameter for low profile and reduced erosion risk, while the proximal portion (toward the generator) has a larger diameter for increased strength and fracture resistance. This local variation in dimensions resolves the contradiction between durability and harm reduction.
Solution Approach 2:
The lead diameter parameter is changed along its length, transitioning from a larger proximal diameter to a smaller distal diameter. This parameter gradient allows the lead to simultaneously achieve the strength needed to resist fracture in high-motion areas and the thin profile needed to minimize skin erosion risk at the implantation site.
2Reliability
If separate anchor systems are used to secure electrodes, then electrode stability can be improved, but implantation complexity increases and migration risk remains
Solution Approach 1:
The anchor features are integrated directly into the electrode lead body rather than being separate components. This merging eliminates the need for separate anchor systems and additional implantation steps, while still providing secure anchoring to prevent migration. The lead itself becomes both the functional electrode and the anchoring structure.
Solution Approach 2:
The electrode lead is designed to be self-anchoring through integrated features such as flared distal ends or tissue-engaging structures that secure the lead in place during implantation without requiring separate anchor devices. The lead serves its own anchoring function, simplifying the overall system.
Data Source
AI summary
Devices and methods for peripheral nerve stimulation with an electrode assembly having a lead body with a tapered transition, at least one anchor, and at least one distal lead configured to connect to the lead body are disclosed.