Implantable Electrode Lead with Active Fixing Elements
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Solution Overview
Problem
Existing extravascular electrode leads for defibrillators require additional incisions for fixation, leading to unwanted scars and increased infection risk due to the need for sutures, and existing anchoring mechanisms are not effective in preventing unintentional displacement of the electrode leads.
Innovation Solution
An implantable extravascular electrode lead with a distal fixing device that can be actuated mechanically or electrically, featuring elastic or bioresorbable fixing elements such as helical elements, claws, or lamellae that securely anchor the lead to tissue without the need for additional incisions, using a catheter to deploy and retract the fixing elements to ensure stable positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional fixation methods using loops and ligatures are used, then the electrode lead can be attached to tissue, but additional incisions are required leading to scars and infection risk
Solution Approach 1:
The harmful elements (sutures, ligatures, additional incisions) are extracted from the fixation process. The patent replaces traditional suture-based fixation with a fixation device that integrates directly onto the electrode lead body, eliminating the need for separate incisions and suturing materials.
Solution Approach 2:
A specialized fixation device acts as an intermediary between the electrode lead and tissue. This device features expansion elements that can be deployed from within the lead body to engage with surrounding tissue, providing secure fixation without requiring external sutures or additional incisions.
2Reliability
If fixation devices are added to prevent displacement, then anchoring security improves, but device complexity increases
Solution Approach 1:
The fixation device is nested within the electrode lead body during the implantation process. The expansion elements are contained within the lead until deployment, whereupon they expand outward to engage with tissue. This nesting approach minimizes the profile during insertion while providing full fixation functionality when needed.
Solution Approach 2:
The fixation device transitions from a compact, low-profile state during implantation to an expanded, high-security state after deployment. The expansion elements can be mechanically actuated to transform from a retracted configuration to an engaged configuration, providing dynamic adaptation to different implantation stages.
3Reliability
If multiple fixing elements are used to prevent displacement, then fixation reliability improves, but tissue damage risk increases
Solution Approach 1:
The fixation device distributes anchoring forces across multiple localized contact points along the electrode lead. Rather than concentrating force at a single point, the expansion elements create multiple discrete engagement points with the tissue, improving overall fixation stability while reducing peak stress on any single tissue location.
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 effectively secures the electrode lead to tissue, preventing migration and reducing the risk of infection by eliminating the need for additional incisions and enhancing fixation without causing tissue damage, thereby ensuring reliable operation of the defibrillator.
Implementation Method 1
fixing elements (230, 250), wherein the fixing elements (230, 250) each have a free end, wherein the fixing elements (230, 250) each can assume a first state and a second state
Data Source
Figure 1
Figure 2a~2b
Figure 2c~2e
AI summary
The implantable extravascular electrode lead(2), having a proximal end (12) and a distal end (13), comprises an electrode lead body (10) that extends from the proximal end (12) of the electrode lead (2) to the distal end (13) of the electrode lead(2), a connecting device arranged at the proximal end (12) of the electrode lead body(10), and a fixing device (20.1, 20.2) arranged in the distal region of the electrode lead body or at the distal end of the electrode lead body. Once the electrode lead has been inserted into an extravascular region of a patient, the fixing device is actively actuatable from outside the body for fixing the electrode lead to patient body tissue.