Implantable Electrode Lead Anchoring Verification via Impedance
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Solution Overview
Problem
Current implant systems for spine stabilization face challenges such as non-uniform load sharing, cyclic loading-induced fatigue, and surgical complications like adhesions and neuroma formation, which complicate the treatment of low back pain by affecting the spinal stabilization system.
Innovation Solution
A system and method for efficiently implanting an electrode lead with fixation elements that can be verified for deployment using impedance measurements, allowing secure anchoring in the lumbar spine to restore muscle function and improve spinal stability, featuring a lead with electrodes, a pulse generator, and software for verifying deployment and adjusting stimulation parameters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If electrode leads are implanted for spine stabilization, then muscle function is restored and spinal stability is improved, but surgical complications such as adhesions and neuroma formation occur
Solution Approach 1:
The patent applies preliminary action by pre-coating the electrode lead surface with a biocompatible material (such as silicone or polyurethane) before implantation. This protective coating is applied in advance to prevent tissue adhesion and neuroma formation during and after surgery, thereby reducing surgical complications while maintaining the therapeutic benefits of spinal stabilization
2Reliability
If fixation elements are used to anchor the lead, then secure anchoring is achieved, but device complexity increases
Solution Approach 1:
The patent merges the fixation element with the electrode lead by integrating anchoring features (such as barbs or expansion elements) directly into the lead structure. This combination eliminates the need for separate fixation devices, reducing overall device complexity while maintaining secure anchoring of the electrode lead in the spinal tissue
3Measurement precision
If impedance measurement verification is implemented, then proper deployment is confirmed, but measurement precision requirements increase
Solution Approach 1:
The patent implements feedback by using impedance measurement to verify the deployment status of fixation elements. The system measures electrical impedance across the electrode lead, and when the fixation elements are properly deployed (embedded in tissue), the impedance value changes to a specific range. This feedback mechanism provides automatic verification of proper deployment without requiring complex external measurement equipment, as the pulse generator itself performs the impedance assessment
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
The system enables efficient and secure implantation of electrode leads, facilitating the restoration of muscle function in the lumbar spine, thereby improving spinal stability and reducing back pain by ensuring proper anchoring and minimizing surgical complications.
Implementation Method 1
The pulse generator may be configured to cause the first or second electrode to emit energy such that the second or first electrode, respectively, receives a portion of the emitted energy
Implementation Method 2
a fixation element coupled to the lead and disposed in proximity to the first electrode, the fixation element configured to transition from a delivery state to a deployed state to anchor the lead to an anchor site
Data Source
AI summary
A system of implanting electrode leads for restoring muscle function to the lumbar spine to treat low back pain is provided. The system provides efficient implantation of the leads, including the ability to verify deployment of anchoring mechanisms on the lead using an impedance assessment, such that 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.