Self-anchoring Implantable Lead with Off-center Pivot

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Solution Overview

Problem

Implantable electrode leads often migrate within the body, leading to therapy failure and unwanted side effects such as pain and frequent device charging, due to their inability to maintain a stable position relative to nerve targets.

Innovation Solution

The development of self-anchoring implantable devices with an anchoring portion and lead connector off-center from a pivot point, allowing the device to be wedged into body tissue upon rotation, and an extraction mechanism for easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single electrode contact lead is used, then the device complexity is reduced, but the lead stability deteriorates causing migration

Engineering Contradiction:

Improvelead structureVSAvoidlead position

Core Design Contradiction:

Device complexityVSStability of the object's composition

Solution Approach 1:

The lead is segmented into functional sections: an electrode contact portion, a body portion with off-center pivot point, and an anchoring portion with barbs. This segmentation allows each section to perform its specific function while maintaining overall simplicity

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The pivot point is deliberately positioned off-center relative to the lead connector, creating an asymmetric configuration. This asymmetry generates rotational torque when force is applied to the lead connector, enabling the anchoring portion to rotate and embed into tissue without requiring complex actuation mechanisms

Inventive Principle:

Principle #4Asymmetry

2Device complexity

If the electrode contact migrates away from the nerve target, then the lead structure remains simple, but the therapy effectiveness deteriorates requiring higher amplitudes

Engineering Contradiction:

Improvelead structureVSAvoidtherapy effectiveness

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The anchoring portion with barbs is pre-configured on the lead body to enable self-anchoring upon insertion. The off-center pivot point is pre-positioned to automatically generate rotational torque during implantation, causing the barbs to embed into tissue and prevent subsequent migration, thereby maintaining electrode contact stability without requiring complex active anchoring mechanisms

Inventive Principle:

Principle #10Preliminary action

3Device complexity

If higher electrical stimulation amplitudes are used to compensate for migration, then the lead structure remains unchanged, but harmful side effects increase

Engineering Contradiction:

Improvelead structureVSAvoidpain and muscle contraction

Core Design Contradiction:

Device complexityVSObject-affected harmful factors

Solution Approach 1:

The anchoring portion with barbs and off-center pivot point configuration provides preliminary anti-action by preventing lead migration before it can cause therapy failure. This proactive anchoring mechanism ensures the electrode remains positioned adjacent to the nerve target, eliminating the need to increase stimulation amplitude and thereby preventing harmful side effects such as pain and unwanted muscle contractions

Inventive Principle:

Principle #9Preliminary anti-action

Data Source

PatentUS9144673B2Self anchoring lead

Publication Date: 2015.09.29 BOSTON SCI NEUROMODULATION CORP

AI summary

An implantable device includes an electrode lead body and at least one stimulating electrode contact disposed on or within the electrode lead body, the lead body being configured and arranged to be self anchoring within body tissue. In addition, the invention is directed to methods of making and using such self anchoring implantable devices.