Hinged Lead Fixation Device for Cranium

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Solution Overview

Problem

Current lead fixation devices for securing brain leads to the cranium often face challenges in preventing movement of the lead's distal end from the target location, especially after the cannula is removed, due to the need for precise placement and the risk of dislodgment during stylet extraction, which can lead to unintended displacement of the lead.

Innovation Solution

A hinged lead fixation device with a skull attachment member and a locking member coupled through a hinge mechanism, featuring a flexible compression mechanism that secures the lead relative to the skull surface, allowing for minimal stress on the lead and preventing movement by creating a holding effect through friction or adhesion, transitioning between open and closed states for easy implantation and secure fixation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If a lead fixation device is used to secure the lead to the cranium, then the lead placement precision is improved, but the risk of lead dislodgment during stylet extraction increases

Engineering Contradiction:
Improvelead placement precisionVSAvoidlead dislodgment risk
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The fixation device is designed to be activated before the stylet is extracted. The compression mechanism is pre-configured to engage with the lead body, creating a holding effect that prevents dislodgment during the critical stylet removal phase. This preliminary securing action ensures the lead remains in place while the stylet is removed from the lead.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The compression mechanism acts as an intermediary element between the fixation device and the lead body. It transmits the securing force from the fixation device to the lead, creating a distributed holding effect that prevents dislodgment without requiring direct mechanical engagement that could cause damage during stylet extraction.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Stability of the object's composition

If a rigid fixation mechanism is used to secure the lead, then the lead stability is improved, but the lead integrity may be compromised

Engineering Contradiction:
Improvelead stabilityVSAvoidlead damage
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The compression mechanism is designed with flexible properties that allow it to conform to the lead body surface while maintaining a securing holding effect. This flexible contact distributes forces across the lead surface, providing stability without the concentrated stress points that would cause damage from rigid fixation mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The fixation device utilizes friction-based holding effects where the compression mechanism creates a holding effect through controlled compression forces. By adjusting the compression level and friction characteristics, the device achieves sufficient stability to prevent dislodgment while maintaining forces below the threshold for lead damage.

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 hinged lead fixation device effectively secures the lead in place relative to the skull surface, reducing the risk of movement and dislodgment, ensuring precise placement and maintaining the lead's integrity by providing a secure holding mechanism without causing damage to the lead.

Implementation Method 1

creating a holding effect through friction or adhesion

Methodology Applied
Scientific EffectFriction: Friction

Implementation Method 2

creating a holding effect through friction or adhesion

Methodology Applied
Scientific EffectAdhesion: Adhesive

Data Source

PatentUS11458302B2Hinged lead fixation devices for securing a lead to a cranium
Publication Date: 2022.10.04 NEUROPACE INC
  • US11458302B2 patent drawing
  • US11458302B2 patent drawing
  • US11458302B2 patent drawing

AI summary

A lead fixation device for securing a portion of a lead relative to a surface of a skull includes a skull attachment member having an upper surface and a lower surface, a locking member having an upper surface and a lower surface and associated with the skull attachment member, and a passageway associated with the locking member and configured to receive the portion of the lead. The skull attachment member and the locking member are configured to rotate relative to each other to transition the lead fixation device between a closed state wherein the lower surface of the skull attachment member and the lower surface of the locking member are generally aligned in a common plane, and an opened state wherein the lower surface of the skull attachment member and the lower surface of the locking member are not aligned in a common plane.