Multi-Electrode Peripheral Nerve Lead Migration Control
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Solution Overview
Problem
Existing temporary implantable neurostimulation leads for sacral nerve stimulation are prone to migration and dislodgement, particularly during daily activities, and often require invasive procedures and subcutaneous tunneling, which can be traumatic for patients and inefficient.
Innovation Solution
A temporarily implantable medical electrical lead with a non-coiled configuration and anchoring devices, such as tine assemblies, that inhibits axial migration and dislodgement, allowing for bipolar operation and percutaneous implantation without the need for subcutaneous tunneling, using a stylet for insertion and external power source for stimulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a permanent neurostimulation lead is implanted within the sacral foramen to resist migration, then the lead stability is improved, but the invasiveness of the procedure increases and the implantation time is extended
Solution Approach 1:
The lead is divided into distinct functional segments: a distal section with electrodes for neural stimulation, an intermediate section with non-coiled insulated wires for flexibility and skin sealing, and a proximal section with connector elements for external device coupling. This segmentation allows each portion to be optimized for its specific function while simplifying the overall implantation process.
Solution Approach 2:
The patent transitions from the traditional coiled three-dimensional wire configuration to a non-coiled linear arrangement for the intermediate wire section. This dimensional change eliminates the complexity of coiling while maintaining electrical connectivity, allowing the wires to be easily sealed to the skin surface and reducing the invasiveness of the procedure.
2Ease of operation
If coiled wire conductors are used to form a continuous channel for minimally invasive implantation, then the ease of implantation is improved, but the wires become prone to migration and dislodgement
Solution Approach 1:
Different sections of the lead possess different structural qualities optimized for their specific functions: the distal section has coiled conductors for flexibility within the foramen, the intermediate section has non-coiled insulated wires for stability and skin sealing, and the proximal section has connector elements for external coupling. This local differentiation resolves the contradiction between ease of implantation and wire stability.
3Reliability
If a subcutaneous tunnel is formed for cable placement to connect the lead to the pulse generator, then the lead protection is improved, but the procedural trauma to the patient increases
Solution Approach 1:
The patent extracts the cable tunneling step from the implantation procedure. Instead of forming a subcutaneous tunnel for cable placement, the intermediate wire section is directly sealed to the skin surface at the foramen site, eliminating the traumatic tunneling procedure while still providing protection and stability for the lead-wire connection.
4Reliability
If multiple electrodes are arranged in an array for bipolar operation, then the stimulation effectiveness is improved, but the lead size increases making implantation more difficult
Solution Approach 1:
The patent arranges multiple electrodes in a linear array along the distal section of the lead, utilizing the longitudinal dimension rather than expanding the transverse diameter. This allows bipolar operation with multiple electrode pairs while maintaining a compact lead size that facilitates minimally invasive implantation through the sacral foramen.
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 lead provides stable and effective electrical stimulation to sacral nerves with reduced migration risk and procedural invasiveness, facilitating a less traumatic and more efficient testing process for patients, enabling bipolar operation and expedited implantation.
Implementation Method 1
at least one anchoring device... which collectively inhibit axial migration of the lead body
Implementation Method 2
a plurality of insulated conductor wires... each having or defining a distal segment, an intermediate segment, and a proximal segment
Implementation Method 3
The distal segment of each of the insulated wires forms a coiled wire lead conductor disposed within the lead body
Data Source
AI summary
A system for applying an electrical stimulation includes a lead and a stylet slidably disposed within a lumen of the lead body and extending proximally therefrom. The lead includes a plurality of insulated conductor wires electrically isolated from one another and each having a distal segment terminating at distal end, an intermediate segment, and a proximal segment terminating at a proximal end, wherein the distal ends are electrically coupled to a respective one of the stimulating electrodes and the intermediate segments extend proximal the lead body and are characterized as having a non-coiled configuration.