Segmented Electrode Lead with X-ray Fluorescent Orientation Capsules

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Solution Overview

Problem

Current deep brain stimulation systems with ring-shaped electrodes deliver undirected stimulation, leading to unwanted side effects due to the inability to target specific neural tissue areas, resulting in inefficient treatment and potential harm to neighboring neural tissue.

Innovation Solution

The development of an implantable lead with segmented electrodes and x-ray fluorescent capsules to indicate the orientation of the electrode array, allowing for precise positioning and directional stimulation through radial current steering, enabling targeted neural tissue stimulation while minimizing unwanted stimulation of adjacent tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If ring-shaped electrodes are used for deep brain stimulation, then the electrode structure is simple and easy to manufacture, but the stimulation cannot be directed to specific positions around the electrode, resulting in unwanted stimulation of neighboring neural tissue

Engineering Contradiction:
Improveelectrode structure simplicityVSAvoidunwanted stimulation of neighboring neural tissue
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The ring electrode is divided into multiple segmented electrodes that can be independently controlled. Each segment can deliver current in specific directions, allowing the stimulation to be directed toward target neural tissue while avoiding neighboring areas. The segments are separated by insulating material to prevent current leakage between adjacent segments.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different segments of the electrode ring are configured with different electrical properties and stimulation parameters tailored to specific directional requirements. Each segment can be independently programmed to stimulate specific neural pathways, creating localized stimulation zones that address the harmful effect of undirected ring electrode stimulation.

Inventive Principle:
Principle #3Local quality

2Object-affected harmful factors

If segmented electrodes are used to enable directional stimulation, then the stimulation can be directed to specific positions, but the device complexity increases due to multiple electrodes and orientation identification requirements

Engineering Contradiction:
Improvedirected stimulation capabilityVSAvoidelectrode array and orientation system complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

X-ray fluorescent capsules are attached to specific segments of the electrode array to serve as orientation markers. These capsules contain materials that fluoresce under X-ray imaging, allowing clinicians to visually identify the spatial orientation and positioning of each electrode segment during implantation and programming, thereby simplifying the complexity of managing multiple segmented electrodes.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The x-ray fluorescent capsules act as intermediary markers between the segmented electrodes and the imaging system. They provide a visual interface that translates the complex three-dimensional arrangement of multiple electrode segments into easily interpretable fluorescent signals on X-ray images, facilitating accurate orientation identification without requiring complex electronic sensors or additional complexity in the electrode structure itself.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If x-ray fluorescent capsules are added to indicate electrode orientation, then the orientation can be identified fluoroscopically, but the device complexity and manufacturing complexity increase

Engineering Contradiction:
Improveelectrode orientation identification accuracyVSAvoidoverall lead structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The x-ray fluorescent capsules are designed as simple, inexpensive attachments that can be easily added to or removed from the electrode segments. They function as temporary orientation markers during implantation and programming, after which their role is complete. This approach provides high measurement precision for orientation identification without permanently increasing the complexity of the implantable device.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The orientation identification function is extracted from the main electrode structure and implemented as separate attachable capsules. This modular approach allows the fluorescent markers to be added only when needed for implantation guidance, and does not require the entire electrode structure to be redesigned with integrated orientation sensors, thereby minimizing the increase in overall device complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

4Object-affected harmful factors

If multiple segmented electrodes are used for current steering, then directional stimulation is achieved, but the manufacturing precision requirements increase

Engineering Contradiction:
Improvestimulation targeting precisionVSAvoidelectrode segment positioning accuracy
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The segmented electrodes are pre-assembled with insulating material and electrical connections established during manufacturing. The relative positions and orientations of the segments are predetermined and fixed during the assembly process, reducing the need for high-precision positioning during implantation. The segments are prepared in advance as integrated units that maintain their geometric relationships throughout the implantation procedure.

Inventive Principle:
Principle #10Preliminary action

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

This solution allows for precise and directed stimulation of specific neural areas, reducing side effects and improving the efficacy of deep brain stimulation treatments by enabling the alignment of stimulation electrodes with target neurons, thereby enhancing treatment outcomes.

Implementation Method 1

at least one capsule including an x-ray fluorescent material and disposed along the distal end of the lead body relative to the electrode array to indicate, when viewed fluoroscopically, an orientation of the electrode array

Methodology Applied
Scientific EffectX-ray fluorescence: Fluorescence

Data Source

PatentEP2830700B1Leads with x-ray fluorescent capsules for electrode identification and methods of manufacture and use
Publication Date: 2017.09.27 BOSTON SCI NEUROMODULATION CORP
  • EP2830700B1 patent drawingFigure 1
  • EP2830700B1 patent drawingFigure 2A~2B
  • EP2830700B1 patent drawingFigure 3

AI summary

An implantable lead for an electrical stimulation system includes a lead body having a distal end, a proximal end, a longitudinal length, and a circumference; a plurality of electrodes disposed along the distal end of the lead body in an electrode array; a plurality of terminals disposed along the proximal end of the lead body; a plurality of conductors electrically coupling the plurality of electrodes to the plurality of terminals; and at least one capsule including an x-ray fluorescent material and disposed along the distal end of the lead body relative to the electrode array to indicate, when viewed fluoroscopically, an orientation of the electrode array. The plurality of electrodes includes a plurality of segmented electrodes. Each of the plurality of segmented electrodes extends partially around the circumference of the lead body.