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

VSEngineering Contradiction Analysis

1Reliability

If sutures are tied around lead bodies for identification, then lead identification is possible, but surgery time is considerably extended

Engineering Contradiction:
Improvelead identification accuracyVSAvoidsurgery time
Core Design Contradiction:
ReliabilityVSLoss of time

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.

Inventive Principle:
Principle #10Preliminary action

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.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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

Engineering Contradiction:
Improvelead connection accuracyVSAvoidcorrection time
Core Design Contradiction:
Ease of operationVSLoss of time

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.

Inventive Principle:
Principle #23Feedback

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.

Inventive Principle:
Principle #32Color changes

3Adaptability or versatility

If multiple lead bodies extend from the spinal region, then therapy coverage is improved, but identification complexity increases

Engineering Contradiction:
Improvetherapy coverageVSAvoidlead identification complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #32Color changes

Data Source

PatentEP2564896B1Lead identification system
Publication Date: 2014.06.25 GREATBATCH LTD
  • EP2564896B1 patent drawingFigure 1
  • EP2564896B1 patent drawingFigure 2
  • EP2564896B1 patent drawingFigure 3

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.