Multi-lead-element stimulation lead with junction coupling

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Solution Overview

Problem

Current implantable electrical stimulation systems face limitations in manufacturing flexibility and cost-effectiveness, particularly in designing leads with multiple elements, as existing methods often require replacing entire leads when malfunctioning parts are identified, and there is a need for more efficient methods to couple distal and proximal lead elements.

Innovation Solution

The development of implantable electrical stimulation leads with a multi-lead-element design, where a distal lead element is coupled to multiple proximal lead elements via a junction, allowing for separate manufacturing and replacement of individual elements, and incorporating a circuit arrangement to electrically connect conductive wires, enhancing manufacturing flexibility and reducing costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If traditional single-lead designs are used, then manufacturing and assembly are simpler, but replacement of malfunctioning components requires replacing the entire lead, increasing cost and reducing manufacturing flexibility

Engineering Contradiction:
Improvemanufacturing flexibilityVSAvoidlead structure complexity
Core Design Contradiction:
Ease of manufactureVSDevice complexity

Solution Approach 1:

The lead body is divided into multiple separate lead elements (first lead element, second lead element, third lead element) that can be manufactured independently and assembled into a complete lead. Each lead element contains specific electrodes and conductive wires, allowing selective replacement of malfunctioning elements without discarding the entire lead assembly.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Multiple lead elements are nested within a common insulator that provides structural support and electrical insulation. The lead elements are positioned in longitudinal alignment within the insulator, creating a compact integrated structure that maintains the benefits of simplicity while enabling modular replacement capability.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of repair

If multi-element lead designs are implemented, then selective replacement of malfunctioning elements is enabled, but the manufacturing process becomes more complex

Engineering Contradiction:
Improveselective element replacementVSAvoidmanufacturing process complexity
Core Design Contradiction:
Ease of repairVSEase of manufacture

Solution Approach 1:

The lead is segmented into replaceable lead elements that can be manufactured separately using standardized processes. Each element contains conductive wires, electrodes, and insulation that can be produced through consistent manufacturing techniques, then assembled into the final multi-element lead structure.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The common insulator serves multiple functions: providing electrical insulation between lead elements, offering mechanical support for all elements, and enabling longitudinal alignment of multiple elements. This universal component simplifies the assembly process despite the multi-element configuration.

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

3Reliability

If entire leads are replaced when malfunctioning parts are detected, then reliability is maintained, but cost increases and manufacturing efficiency decreases

Engineering Contradiction:
Improvesystem reliabilityVSAvoidmanufacturing efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

By segmenting the lead into independent replaceable elements, the system maintains reliability through selective replacement of only the malfunctioning element rather than the entire lead. This segmentation enables quality control at the element level and allows defective elements to be identified and replaced individually, improving manufacturing efficiency and reducing waste.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The modular lead element design enables discarding only the specific malfunctioning element while recovering and retaining functional elements. This approach reduces material waste and manufacturing costs compared to replacing entire leads, while maintaining system reliability through replacement of the defective component.

Inventive Principle:
Principle #34Discarding and recovering

Data Source

PatentUS9238132B2Systems and methods for making and using electrical stimulation systems having multi-lead-element lead bodies
Publication Date: 2016.01.19 BOSTON SCI NEUROMODULATION CORP
  • US9238132B2 patent drawing
  • US9238132B2 patent drawing
  • US9238132B2 patent drawing

AI summary

A lead for providing electrical stimulation of patient tissue includes a distal lead element, at least two proximal lead elements, and a junction coupling the distal lead element to each of the at least two proximal lead elements. The distal lead element includes a plurality of electrodes and a plurality of conductive wires coupled to the plurality of electrodes and extending along a longitudinal axis of the distal lead element. Each of the at least two proximal lead elements includes a plurality of terminals and a plurality of conductive wires coupled to the plurality of terminals and extending along a longitudinal axis of the proximal lead element. The junction includes a circuit arrangement electrically coupling each of the conductive wires of the distal lead element to at least one of the conductive wires of at least one of the at least two proximal lead elements.