Lateral Epidural Lead for Nerve Root Stimulation
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Solution Overview
Problem
Dorsal root ganglion stimulation is a complex procedure with high complication rates due to painful lead placement through the foramen, potential lead fracture, and exacerbated foraminal stenosis, requiring multiple leads for effective pain relief.
Innovation Solution
A system with a bendable, pre-formed lead body implanted in the lateral epidural space, featuring adjustable electrode placement and spacing to target specific nerve roots and dorsal root ganglions, reducing the number of leads and electrodes while improving accuracy and safety.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If dorsal root ganglion stimulation is performed through the foramen, then targeted stimulation distribution is achieved, but lead fracture risk and procedural complexity increase
Solution Approach 1:
The patent introduces an intermediary approach by placing the lead in the epidural space rather than directly through the foramen. This intermediate position allows the electrodes to reach the dorsal root ganglion through the natural curvature of the spine, avoiding direct foramen penetration while maintaining stimulation accuracy. The epidural space acts as a mediator that enables targeted stimulation without the mechanical stress and fracture risk associated with direct foramen placement.
2Adaptability or versatility
If multiple leads are used to cover pain relief area, then comprehensive pain coverage is achieved, but device complexity and complication rate increase
Solution Approach 1:
The patent applies segmentation by dividing a single lead into multiple functional electrodes along its length. Each electrode can be independently controlled to target specific dermatomes or pain regions. This segmented electrode design within one lead replaces the need for multiple separate leads, reducing overall device complexity while maintaining comprehensive pain coverage through selective electrode activation.
Solution Approach 2:
The single lead with multiple electrodes serves multiple functions that would traditionally require separate leads. It can target different dermatomes, adjust stimulation parameters for various pain conditions, and provide comprehensive coverage across multiple spinal levels. This multi-functional design consolidates what would otherwise require multiple specialized leads into one versatile device.
3Ease of operation
If lead is placed through the foramen for dorsal root ganglion stimulation, then natural anchoring is achieved, but procedural pain and foraminal stenosis exacerbation increase
Solution Approach 1:
The patent inverts the traditional approach by placing the lead in the epidural space rather than through the foramen. This reversal allows the lead to achieve stable positioning through the natural epidural anatomy without forcing passage through the narrowed foramen. The inversion eliminates the need to exacerbate foraminal stenosis or cause procedural pain associated with foramen penetration, while still enabling dorsal root ganglion stimulation through the epidural pathway.
Data Source
Figure 1A~1B
Figure 2A~2D
Figure 3A~3H
AI summary
A system comprises a bendable, pre-formed lead body operable to be implanted proximate a neural pathway of a patient. A first electrode comprising a plurality of first segments at a first longitudinal location of the lead body is configured to be positioned at a lateral epidural region proximate at least one nerve root of the patient, and a second electrode comprising a plurality of second segments at a second longitudinal location of the lead body is configured to be positioned along a midline of the patient's spinal column. The system further includes a signal generator electrically coupled to at least one of the first and second electrodes and a processor coupled to the signal generator and operable to apply a stimulation signal to at least one of the first and second electrodes.