Neuromodulation Lead Anchor Mesh for Reversible Anti-Migration Clamping
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Solution Overview
Problem
Existing neuromodulation lead anchors face issues with irreversible changes, complexity, and risk of migration due to axial forces, requiring specialized tools and posing risks of damage to leads during adjustment or removal.
Innovation Solution
A lead anchor with a mesh made of shape memory metal, such as nitinol, that provides a reversible clamping mechanism using a set screw, distributing mechanical forces to secure the lead without damaging it, allowing for flexible repositioning and adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional passive lead anchoring system with a silicone body and hollow cylindrical portion is used, then the lead can be passed through and secured in place, but the system does not provide resistance to axial forces causing lead migration
Solution Approach 1:
The anchor is divided into distinct functional segments: a compression element that contacts the lead, a locking mechanism with movable portion, and a body portion. This segmentation allows each component to specialize in resisting specific forces, with the compression element providing axial force resistance and the locking mechanism preventing migration.
Solution Approach 2:
The locking mechanism incorporates a movable portion that can transition between locked and unlocked states dynamically. This dynamic capability allows the anchor to be adjusted during implantation and therapy, enabling repositioning when needed while providing stable fixation during normal operation.
2Reliability
If adhesive-based locking mechanisms are used to fix the anchor to the lead, then the lead position is secured, but the anchor cannot be adjusted or repositioned if therapy improvement is needed
Solution Approach 1:
The locking mechanism uses a movable portion that can be actuated to transition between locked and unlocked states. This dynamic design replaces permanent adhesive bonding with a reversible mechanical locking system, allowing the lead to be securely held during therapy while enabling repositioning if therapeutic outcomes need adjustment.
Solution Approach 2:
The mechanical locking mechanism allows for recovery of the lead's mobility by unlocking and repositioning, unlike adhesive systems where the bond is permanently discarded. The movable portion can be actuated to release the lock, enabling the lead to be repositioned and re-secured without removing the entire anchor system.
3Reliability
If snapping mechanisms are used that click into place through twisting or pinching, then the lead is secured, but the system requires hand actuation and may risk patient actuation during lifetime
Solution Approach 1:
The manual twisting or pinching action is replaced with a more controlled mechanical actuation system. The movable portion can be actuated by a tool or controlled mechanism rather than requiring manual hand manipulation, reducing the risk of unintended actuation while maintaining secure locking capability.
4Reliability
If set screw mechanisms are used to compress the lead under the screw tip, then the lead is clamped securely, but the complexity increases and unique designs are required for each lead system
Solution Approach 1:
The anchor design with a standardized body portion and configurable compression element can accommodate different lead types and configurations. This universal design approach reduces the need for unique custom designs for each lead system while maintaining secure clamping capability through the movable locking mechanism.
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 secure anchoring without lead damage, reduces complexity, and allows for reversible adjustments, minimizing migration risks and the need for specialized tools.
Implementation Method 1
A lead anchor with a mesh made of shape memory metal, such as nitinol, that provides a reversible clamping mechanism
Implementation Method 2
distributing mechanical forces to secure the lead without damaging it
Data Source
AI summary
A lead anchor for a neuromodulation lead has an anchor body that receives a portion of the lead. A mesh is arranged so as to at least partially surround the portion of the lead when the portion of the lead is received in the anchor body.