Deployable Intermediate Portion for Strain-Relieving Electrical Stimulation Lead

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Solution Overview

Problem

Current implantable electrical stimulation systems face challenges in maintaining the precise positioning and flexibility of electrodes due to tissue movement and anatomical changes, which can lead to ineffective stimulation and potential discomfort or complications.

Innovation Solution

The development of an electrical stimulation lead with a deployable intermediate portion that can transition from a cylindrical to a non-cylindrical configuration, featuring separation elements that can be deployed using mechanical, chemical, or light-activated mechanisms, allowing for increased flexibility and decoupling between the distal and extension portions to accommodate tissue movement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If the lead body is made rigid to maintain electrode positioning, then positioning stability is improved, but flexibility and ability to accommodate tissue movement deteriorate

Engineering Contradiction:

Improveelectrode positioning stabilityVSAvoidflexibility to accommodate tissue movement

Core Design Contradiction:

Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The lead body is divided into multiple sections: a proximal cylindrical portion, a distal cylindrical portion, and an intermediate non-cylindrical portion. The intermediate portion includes separation elements that can be deployed to create spacing between conductor groups, allowing the lead to adapt to tissue movement while maintaining electrode positioning stability through the rigid cylindrical end portions.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The intermediate portion of the lead body is designed to be deployable from a compressed state to an expanded state. Separation elements can be actuated to change the configuration of the intermediate portion, transitioning the lead from a compact cylindrical shape to an expanded non-cylindrical shape with spaced conductor groups, providing dynamic adaptability to tissue movement.

Inventive Principle:

Principle #15Dynamics

2Adaptability or versatility

If the lead body is made flexible to accommodate tissue movement, then adaptability is improved, but electrode positioning stability deteriorates

Engineering Contradiction:

Improveflexibility to accommodate tissue movementVSAvoidelectrode positioning stability

Core Design Contradiction:

Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The lead body is segmented into rigid cylindrical end portions that maintain positioning stability and a flexible intermediate portion that accommodates tissue movement. The intermediate portion contains separation elements that can be deployed to space out conductor groups while the cylindrical end portions remain rigid to ensure stable electrode positioning.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

Different portions of the lead body have different mechanical properties: the proximal and distal cylindrical portions are rigid to maintain positioning stability, while the intermediate non-cylindrical portion is more flexible to accommodate tissue movement. This local differentiation of mechanical properties allows the lead to simultaneously achieve both stability and adaptability.

Inventive Principle:

Principle #3Local quality

3Adaptability or versatility

If separation elements are deployed to space conductors apart, then flexibility and strain relief are improved, but device complexity increases

Engineering Contradiction:

Improvestrain relief capabilityVSAvoidlead structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The separation elements are nested within the intermediate portion of the lead body in a compressed state during implantation. After implantation, the separation elements can be deployed from this nested configuration to expand the intermediate portion and space the conductor groups apart, providing strain relief without adding significant complexity to the overall lead structure.

Inventive Principle:

Principle #7Nested doll (Nesting)

Solution Approach 2:

The intermediate non-cylindrical portion acts as an intermediary element between the proximal and distal cylindrical portions. It contains the separation elements that can be deployed to provide strain relief and flexibility, mediating between the rigid end portions and allowing relative movement while maintaining overall lead integrity.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS10576269B2Force-decoupled and strain relieving lead and methods of making and using

Publication Date: 2020.03.03 BOSTON SCI NEUROMODULATION CORP

AI summary

An electrical stimulation lead includes a lead body having a distal end portion, a proximal end portion, and a longitudinal length; terminals disposed along the proximal end portion of the lead body; electrodes disposed along the distal end portion of the lead body; and conductors extending along the lead body and electrically coupling the terminals to the electrodes. The lead body includes an intermediate portion disposed between the proximal end portion and the distal end portion. The intermediate portion includes at least one separation element that extends longitudinally along the intermediate portion and the intermediate portion is deployable from an undeployed configuration to a deployed configuration responsive to operation of the at least one separation element.