Electrode Lead Midline-to-Lateral Implantation
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Solution Overview
Problem
Current implantation methods for electrode leads in the lumbar spine face challenges such as high stress locations and dislodgement due to anatomical structures, particularly the thoracolumbar fascia, which complicates the delivery of effective therapy for treating low back pain.
Innovation Solution
A method and system for implanting an electrode lead using a guide needle and delivery needle with a midline-to-lateral trajectory, avoiding the crisscross environment of the thoracolumbar fascia, and utilizing fixation elements that self-expand to anchor the lead securely within the muscle, ensuring stable placement and reducing the risk of dislodgement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current implantation methods are used to deliver electrode leads, then the leads can be implanted in the lumbar spine, but the leads experience high stress and dislodgement due to the crisscross environment of the thoracolumbar fascia
Solution Approach 1:
The patent extracts the electrode lead from the problematic crisscross environment of the thoracolumbar fascia by creating a dedicated tunnel through the fascia midline. The lead is delivered through this tunnel rather than being routed through the fascial layers, thereby removing it from the harmful stress environment while maintaining its functional position for stimulating the lumbar spine muscles.
Solution Approach 2:
The patent introduces a midline fascial tunnel as an intermediary pathway for lead delivery. This tunnel acts as a protected conduit that allows the lead to pass through the thoracolumbar fascia without being subjected to the crisscross stress environment. The tunnel is created using a needle tract that is then dilated and used to deliver the lead securely.
2Ease of operation
If the electrode lead is routed through the thoracolumbar fascia, then the lead can reach the target muscle, but the lead is subjected to high stress from the crisscross fascial environment
Solution Approach 1:
The patent extracts the lead delivery path from the harmful crisscross fascial environment by creating a dedicated midline tunnel. Instead of routing the lead through the complex fascial layers where it would experience stress, the lead is delivered through a straight tunnel created perpendicular to the fascial plane, removing it from the harmful environment while maintaining ease of delivery.
Solution Approach 2:
The patent performs preliminary action by creating the midline fascial tunnel before delivering the electrode lead. A needle is first inserted to create the tunnel tract, then the needle is removed and the tract is dilated. This preliminary tunnel creation establishes a protected pathway that simplifies subsequent lead delivery and protects the lead from fascial stress.
3Ease of manufacture
If fixation elements are not used, then the implantation procedure is simpler, but the lead is at risk of dislodgement
Solution Approach 1:
The patent applies self-service through fixation elements that automatically expand upon deployment to anchor the lead in place. The fixation elements are delivered in a compressed state within the lead, then upon exiting the delivery catheter, they self-expand to engage the surrounding tissue, providing automatic anchoring without requiring additional surgical steps or manual intervention.
Solution Approach 2:
The fixation elements transition from a static compressed state during delivery to a dynamic expanded state upon deployment. This dynamic transformation allows the elements to adapt to the surrounding tissue geometry, maximizing anchoring effectiveness while maintaining a compact profile during the implantation procedure.
Data Source
AI summary
Systems and methods for enhanced implantation of an electrode lead for neuromuscular electrical stimulation of tissue associated with control of the lumbar spine for treatment of back pain, in a midline-to-lateral manner are provided. The implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system without disruption of the electrode lead post-implantation due to anatomical structures.