Expandable Wire Fixation for Implantable Stimulation Leads
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Solution Overview
Problem
Current neurostimulation lead fixation methods, such as suturing and using tined leads, are invasive, causing patient discomfort and potential lead migration, which can undermine therapy efficacy and complicate explantation.
Innovation Solution
A minimally invasive fixation mechanism using expandable wire-like elements with elastic or super-elastic properties, restrained by a mechanism like a lead introducer or stylet, that expands radially to secure the lead to surrounding tissue without surgical implantation, facilitating easier explantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If suturing is used to secure the lead, then lead fixation is achieved, but invasive surgery is required causing patient discomfort and increased recovery time
Solution Approach 1:
The patent replaces the mechanical suture system with an expandable fixation mechanism consisting of wire-like elements that expand radially to engage surrounding tissue. This substitution eliminates the need for invasive suturing while achieving reliable lead fixation through the expandable structure's interaction with tissue.
Solution Approach 2:
The fixation mechanism utilizes materials with elastic or super-elastic properties that change their physical state upon expansion. The wire-like elements transition from a compressed state during insertion to an expanded state for fixation, leveraging parameter changes in material properties to achieve fixation without invasive surgery.
2Stability of the object's composition
If traditional fixation methods are used, then lead stability is improved, but explantation becomes more difficult
Solution Approach 1:
The fixation mechanism is designed to be dynamic rather than static. The wire-like elements can be compressed during insertion for minimally invasive placement, then expand to provide stable fixation. For explantation, the same elements can be compressed again to release the lead, providing ease of removal while maintaining stability during use.
Solution Approach 2:
The fixation mechanism consists of multiple discrete wire-like elements that can be independently compressed and expanded. This segmentation allows the fixation to be applied and removed in a controlled manner, providing stability during implantation while facilitating easy explantation through sequential compression of individual elements.
3Reliability
If a fixation mechanism is added to the lead, then lead migration is prevented, but device complexity increases
Solution Approach 1:
The wire-like elements serve multiple functions: they provide fixation when expanded, and they can be compressed for minimally invasive insertion. The same structural elements perform both fixation and insertion functions, reducing the need for separate components and simplifying the overall device while preventing lead migration.
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
This solution effectively fixes the neurostimulation lead in place, reducing patient pain and recovery time, preventing lead migration, and simplifying the explantation process while maintaining therapy efficacy.
Implementation Method 1
The material of the wire-like elements may have elastic or super-elastic properties that cause the wire-like elements to expand against surrounding tissue
Implementation Method 2
The material of the wire-like elements may have elastic or super-elastic properties that cause the wire-like elements to expand against surrounding tissue
Data Source
AI summary
An implantable electrical stimulation lead includes an integrated fixation mechanism that expands upon implantation of the lead to fix the lead relative to a target tissue site, such as tissue within the epidural region proximate the spine or the sacral foramen. The fixation mechanism may include one or more expandable wire-like elements, which may be configured in a substantial helical shape. The wire-like elements may be formed from an elastic or super-elastic material, and expand radially outward when a restraint mechanism is removed following implantation of the lead.