Color-Coded Lead Indicators for Neurostimulation Implantation
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Solution Overview
Problem
Current neurostimulation systems face challenges in efficiently identifying and connecting multiple leads during implantation, leading to increased surgery time and potential errors in lead placement, which can result in sub-optimal therapy.
Innovation Solution
A lead identification system utilizing removable indicators such as color, tactile, or alpha-numeric markers allows surgeons to track electrodes to corresponding connectors on the pulse generator, reducing the complexity of lead identification and connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sutures are tied around lead bodies for identification, then lead identification is possible, but surgery time is considerably extended
Solution Approach 1:
Color indicators are pre-attached to lead bodies before implantation, eliminating the need for time-consuming suture tying during surgery. The indicators are already in place to facilitate quick visual identification and matching of leads to corresponding ports on the IPG.
Solution Approach 2:
The mechanical suture-tying process is replaced with a visual identification system using color-coded indicators. This substitution eliminates the manual, time-consuming mechanical action of tying sutures while maintaining reliable lead identification through color matching.
2Ease of operation
If lead bodies are inserted into incorrect connector ports, then connection errors occur, but additional surgical time is wasted to identify and correct the problem
Solution Approach 1:
Color indicators provide immediate visual feedback during the connection process. The surgeon can quickly verify that each lead is connected to the correct port by matching colors, enabling real-time error detection and prevention rather than discovering mistakes after completion.
Solution Approach 2:
Different colors are assigned to different lead bodies to create a visual coding system. This color-coding enables rapid visual verification of correct lead-to-port matching, eliminating the need for time-consuming identification and correction of connection errors.
3Adaptability or versatility
If multiple lead bodies extend from the spinal region, then therapy coverage is improved, but identification complexity increases
Solution Approach 1:
The identification system segments the complex task of tracking multiple leads by assigning distinct color indicators to each lead body. This segmentation transforms a complex identification problem into simple, independent color-matching tasks for each individual lead.
Solution Approach 2:
Color indicators are used to differentiate between multiple lead bodies, providing a simple visual coding system that scales with the number of leads. Each lead receives a unique color identifier, making it easy to track and connect multiple leads without increasing identification complexity.
Data Source
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AI summary
A lead identification system for tracking a plurality of neurostimulation leads during implantation in a patient, and a method of using the same. The lead identification system includes a plurality of lead indicators each adapted to attach to one of a plurality of epidural needles to identify the leads. At least one clip adapted to releasably attach to proximal ends of the leads is provided with corresponding lead indicators. The trial cable for conducting trial stimulation includes connectors with corresponding lead indicators. A plurality of lead indicator stylets are provided for insertion into lumens at the proximal ends of the leads. The pulse generator also has connectors with corresponding lead indicators. The various lead indicators permit a surgeon to track a particular lead to the corresponding connectors on the pulse generator.