Adjustable Sheath Peripheral Nerve Stimulation Lead
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Solution Overview
Problem
Conventional spinal cord stimulation leads may not provide the desired preferences or advantages for peripheral nerve stimulation, such as customizable electrode exposure and size, leading to suboptimal stimulation volumes and potential migration issues.
Innovation Solution
An electrical stimulation lead with a customizable sheath that can be adjusted to expose a selected portion of the electrode for stimulation, made from biocompatible materials like silicone or polyurethane, and a guidewire system for precise placement of the lead near peripheral nerves, allowing for adjustable electrode length and reduced lead profile for shallow targets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional spinal cord stimulation leads are used for peripheral nerve stimulation, then the lead structure is simple and standardized, but the stimulation volume is suboptimal and electrode exposure cannot be customized
Solution Approach 1:
The lead incorporates a movable sheath that can be adjusted along the lead body to expose different lengths of the electrode. This dynamic adjustment mechanism allows the electrode exposure length to be customized after implantation, enabling adaptation to different peripheral nerve stimulation requirements while using a standardized lead structure.
Solution Approach 2:
The lead is divided into distinct functional segments: a standardized lead body, a movable sheath, and an electrode portion. This segmentation allows the electrode exposure to be independently adjusted by moving the sheath, providing customization without requiring complete redesign of the entire lead structure.
2Reliability
If fixed electrode exposure is used, then the lead structure is simple, but lead migration occurs and stimulation effectiveness decreases
Solution Approach 1:
The movable sheath mechanism allows the electrode exposure length to be adjusted and locked at different positions, preventing lead migration by providing a customizable fit that can be optimized for each patient's anatomy and stimulation requirements.
Solution Approach 2:
The system allows changing the effective electrode exposure parameter by moving the sheath, enabling optimization of stimulation effectiveness without requiring lead replacement or surgical intervention for migration issues.
3Volume of stationary object
If larger electrode exposure is used to increase stimulation volume, then the stimulation effectiveness improves, but the lead profile increases and may cause migration issues
Solution Approach 1:
The movable sheath allows dynamic adjustment of the exposed electrode length, enabling the stimulation volume to be optimized independently of the overall lead profile. The sheath can be positioned to expose only the necessary electrode length, maintaining a compact lead profile while achieving adequate stimulation volume.
Solution Approach 2:
The sheath covers portions of the electrode to create localized exposure zones, allowing the stimulation volume to be concentrated where needed while keeping the overall lead structure compact and reducing migration risk.
Data Source
AI summary
An electrical stimulation lead includes a lead body; a terminal disposed along the proximal end portion of the lead body; a single electrode disposed at the distal end of the lead body; a conductor extending along the lead body and electrically coupling the terminal to the single electrode; and an adjustable sheath disposed over a portion of the lead body to cover a selected portion of the single electrode by displacing the sheath forwards or backwards relative to the single electrode to control a size of a portion of the electrode exposed for stimulation of tissue. Another electrical stimulation lead has a low-profile distal portion that has a smaller lateral width in at least one direction than a remainder of the lead body. Yet another arrangement includes a guidewire with a mapping electrode to map a region around a peripheral nerve prior to implantation of an electrical stimulation lead.