Lead Positioning and Fixation System for Nerve Stimulation

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Solution Overview

Problem

Implantable medical leads used for nerve stimulation often become dislodged due to ambulatory stresses, requiring repositioning and increasing the risk of nerve damage and reduced efficacy, as the torque applied during implantation is not uniformly transmitted, leading to displacement of electrodes relative to the target nerve tissue.

Innovation Solution

A therapy assembly with fixation structures that collapse inward during insertion into an introducer and deploy when the introducer is retracted, providing symmetrical resistance and ensuring that torque is transmitted effectively to the distal end, maintaining precise rotational alignment and securing the electrodes in place.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If fixation structures are deployed during implantation, then electrode stability is improved, but torque transmission becomes non-uniform causing electrode displacement

Engineering Contradiction:

Improveelectrode stabilityVSAvoidelectrode rotational alignment

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The fixation structures are deployed in advance during the implantation procedure before final electrode positioning, allowing them to provide stable anchoring throughout the remainder of the procedure and prevent displacement during patient ambulation

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The introducer device allows dynamic adjustment of electrode position during implantation while the fixation structures remain collapsed and flexible, enabling torque transmission and rotational alignment adjustments. Once positioning is complete, the fixation structures are deployed to lock the electrode in place

Inventive Principle:

Principle #15Dynamics

2Ease of operation

If the introducer is removed early, then electrode positioning flexibility is improved, but fixation structures cannot be properly deployed

Engineering Contradiction:

Improveelectrode positioning flexibilityVSAvoidfixation structure deployment

Core Design Contradiction:

Ease of operationVSEase of manufacture

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The introducer device serves as an intermediary that maintains the fixation structures in a collapsed, flexible state during positioning, then allows their deployment when the introducer is removed, enabling both positioning flexibility and proper fixation

Inventive Principle:

Principle #24Intermediary (Mediator)

3Strength

If fixation structures are made rigid, then anchoring strength is improved, but torque transmission and rotational alignment are compromised

Engineering Contradiction:

Improveanchoring strengthVSAvoidtorque transmission

Core Design Contradiction:

StrengthVSEase of operation

Solution Approach 1:

The fixation structures transition from a flexible, collapsed state during implantation that allows torque transmission and rotational adjustment to a rigid, deployed state after positioning that provides strong anchoring strength to prevent dislodgement

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The physical state of the fixation structures changes from flexible to rigid through deployment, altering their mechanical properties to provide both torque transmission capability during positioning and anchoring strength after positioning is complete

Inventive Principle:

Principle #35Parameter changes

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

The solution ensures stable electrode placement, reducing the risk of nerve damage and maintaining consistent nerve response, as it allows for efficient torque transmission and secure anchoring of the therapy delivery element, thereby enhancing the longevity and effectiveness of nerve stimulation.

Implementation Method 1

A plurality of fixation structures are disposed radially around the therapy delivery element proximate the electrodes. The fixation structures are configured to collapse inward to a collapsed configuration when inserted into the lumen of the introducer and to deploy to a deployed configuration when the introducer is retracted.

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Implementation Method 2

A fitting is located at proximal end of the introducer that releasably locks the therapy delivery element to the introducer, such that torque applied to the fitting is substantially transmitted to the distal end of the therapy assembly.

Methodology Applied

Scientific EffectTorque transmission: Torque

Data Source

PatentUS9095700B2Lead positioning and fixation system

Publication Date: 2015.08.04 CIRTEC MEDICAL CORP

AI summary

A therapy assembly configured for at least partial insertion in a living body. A plurality of fixation structures are disposed radially around the therapy delivery element proximate the electrodes. The fixation structures include wires having a diameter in a range between about 0.004 inches and about 0.020 inches. The wires have a first end attached to the therapy delivery element and a second end attached to a sliding member configured to slide along the therapy delivery element. The fixation structures are configured to collapse inward to a collapsed configuration when inserted into a lumen of an introducer and to deploy to a deployed configuration when the introducer is retracted. A fitting is located at proximal end of the introducer that releasably locks the therapy delivery element to the introducer, such that torque applied to the fitting is substantially transmitted to the distal end of the therapy assembly.