Neuromodulation Adapter for Legacy Lead Compatibility

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Solution Overview

Problem

Incompatibility between legacy and next-generation sacral nerve stimulation leads and neurostimulator devices due to variations in electrode number, contact spacing, diameter, and set screw configurations limits the ability to replace neurostimulator devices without replacing the stimulation leads, which is a more invasive procedure.

Innovation Solution

A neuromodulation adapter with a proximal portion configured to engage with neurostimulator devices and a distal portion with a different pitch spacing to match the stimulation leads, allowing for electrical compatibility between previously implanted leads and replacement devices, including a flexible design for optimal positioning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If the electrical connector size is reduced for newer smaller neurostimulator devices, then the device form factor is improved, but compatibility with legacy stimulation leads is lost

Engineering Contradiction:
Improveneurostimulator device sizeVSAvoidlead compatibility
Core Design Contradiction:
Volume of moving objectVSAdaptability or versatility

Solution Approach 1:

An adapter is introduced as an intermediary component between the neurostimulator device and the stimulation lead. The adapter includes a first electrical connector that interfaces with the neurostimulator device and a second electrical connector that interfaces with the stimulation lead, enabling compatibility between components with different connector specifications

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The adapter serves multiple functions: it provides electrical connection between incompatible components, maintains mechanical coupling, and enables the use of legacy leads with new devices. This multi-functionality resolves the contradiction by allowing the small neurostimulator device to work with various lead types

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

2Ease of manufacture

If the electrical connector pitch spacing is changed in newer devices, then the device design is optimized, but compatibility with existing leads is reduced

Engineering Contradiction:
Improvedevice design optimizationVSAvoidelectrical connection compatibility
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The adapter acts as a pitch conversion intermediary, with connector elements spaced at a first pitch for the neurostimulator device and conductor elements spaced at a second pitch for the stimulation lead. This allows electrical connection between components with different pitch specifications while maintaining optimized device design

Inventive Principle:
Principle #24Intermediary (Mediator)

3Duration of action of moving object

If the neurostimulator device is replaced to extend system lifespan, then the device battery lifetime is improved, but the procedure becomes more invasive if the lead must also be replaced

Engineering Contradiction:
Improvebattery lifetimeVSAvoidreplacement procedure invasiveness
Core Design Contradiction:
Duration of action of moving objectVSEase of operation

Solution Approach 1:

The adapter enables replacement of the neurostimulator device while retaining the existing stimulation lead. By providing electrical compatibility between the new device and legacy lead, the adapter allows less invasive replacement procedures, improving ease of operation while maintaining extended system lifespan

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS11575236B2Implantable pulse generator carrier used to interface with multiple lead sizes
Publication Date: 2023.02.07 MEDTRONIC INC
  • US11575236B2 patent drawing
  • US11575236B2 patent drawing
  • US11575236B2 patent drawing

AI summary

An apparatus and method of electrically coupling a previously implanted stimulation lead with a replacement neurostimulator device. The apparatus and method configured to operably couple a proximal portion of a neuromodulation adapter including a plurality of electrical conductors spaced apart at a first pitch spacing to a corresponding plurality of electrical terminals of a replacement neurostimulator device, and operably couple a distal end of the neuromodulation adapter including a plurality of conductor elements and an electrically active set screw spaced part of a second pitch spacing to a corresponding plurality of electrical connectors of a previously implanted stimulation lead.