Segmented Electrode Leads With Alignment Features

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Solution Overview

Problem

Conventional electrical stimulation leads with ring electrodes lack directional control, leading to undirected stimulation of neural tissue and potential side effects due to the inability to target specific areas around the electrode, resulting in unwanted stimulation of neighboring neural tissue.

Innovation Solution

The development of segmented electrodes with alignment features, such as cutouts and notches, allows for precise placement and orientation during manufacturing, enabling radial current steering and targeted stimulation by forming a lead with sets of electrodes that extend only partially around the circumference, allowing for three-dimensional targeting of neural tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If ring electrodes are used to provide stimulation, then the stimulation can be delivered to target neurons, but the stimulus current cannot be directed to specific positions around the ring electrode resulting in undirected stimulation of neighboring neural tissue

Engineering Contradiction:
Improvestimulation targeting precisionVSAvoidundirected stimulation of neighboring tissue
Core Design Contradiction:
Measurement precisionVSObject-generated harmful factors

Solution Approach 1:

The ring electrode is divided into multiple discrete contact elements arranged around the circumference of the lead. Each contact element can be independently controlled to deliver stimulation current to specific angular positions, enabling directional control of the stimulation field while maintaining the ability to stimulate target neurons.

Inventive Principle:
Principle #1Segmentation

2Manufacturing precision

If segmented electrodes with alignment features are used, then precise placement and orientation during manufacturing is enabled, but the device complexity increases

Engineering Contradiction:
Improveelectrode placement precisionVSAvoidelectrode structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

Alignment features such as notches, slots, or protrusions are incorporated into the electrode structure during manufacturing to establish precise angular orientation. These features guide the positioning of contact elements relative to the lead during assembly, ensuring consistent and accurate placement without requiring complex post-manufacturing adjustment.

Inventive Principle:
Principle #10Preliminary action

3Adaptability or versatility

If multiple contact elements are used around the circumference, then directional control of stimulation is achieved, but the number of electrodes and manufacturing complexity increases

Engineering Contradiction:
Improvecurrent steering capabilityVSAvoidnumber of electrodes
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The contact elements are designed to serve multiple functions: they provide stimulation current delivery, enable directional control through selective activation, and incorporate alignment features for precise manufacturing. This multi-functionality reduces the need for separate components and minimizes the overall number of elements required.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentEP3003466B1Segmented electrode leads formed from pre-electrodes with alignment features and methods of making the leads
Publication Date: 2019.07.17 BOSTON SCI NEUROMODULATION CORP
  • EP3003466B1 patent drawingFigure 1
  • EP3003466B1 patent drawingFigure 2
  • EP3003466B1 patent drawingFigure 3A~3D

AI summary

A pre-electrode for a stimulation lead includes a general iy cylindrical body having an exterior surface, an interior surface, a proximal end, and a distal end. The body includes multiple segmented electrodes disposed along the body; connecting material disposed along the outer surface of the body and coupling each of the segmented electrodes to one another; and multiple cutouts defined between adjacent segmented electrodes. The body also includes one or more of the following 1) a end wall step section formed in the exterior surface of the body on either the distal end or the proximal end of the body; 2) an alignment feature selected fr om a slot or a notch extending inwardly from the exterior surface of the body, or 3) a longitudinal step section formed in the exterior surface of the body.