Erectable Lead Spinal Electrode Design
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Solution Overview
Problem
Traditional implantable medical electrodes with coplanar lead configurations face challenges in precise placement and migration issues due to bending moments and insecure anchoring, leading to potential displacement during body movement and difficulty engaging bony windows for secure implantation.
Innovation Solution
An electrode design with a lead that can be positioned coplanar with the top surface and erected away from it, allowing for angled emergence and secure engagement with bony openings, reducing bending moments and improving anchoring stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the lead wire and strain relief are configured coplanar with the paddle electrode, then the assembly can be advanced through the spinal canal opening more easily, but the lead must be bent as it emerges through the bony window, introducing a bending moment that causes paddle migration
Solution Approach 1:
The lead wire is configured to emerge from the paddle at an angle perpendicular to the coplanar plane, transitioning from a 2D coplanar arrangement to a 3D angular configuration. This dimensional change allows the lead to exit through the bony window without bending while the paddle remains stable, resolving the contradiction between ease of advancement and position stability.
2Ease of manufacture
If the lead wire emerges coplanar from the bottom edge of the paddle, then manufacturing is easier, but the electrode placement is challenging and requires precise positioning to avoid stimulating unintended tissue
Solution Approach 1:
The lead wire configuration is made adjustable between coplanar and angled positions, transforming a static manufacturing constraint into a dynamic, adaptable structure. This allows the lead to be positioned optimally during implantation while maintaining manufacturing simplicity, resolving the contradiction between ease of manufacture and placement precision.
3Reliability
If traditional anchoring techniques are used to secure the paddle electrode, then the electrode can be anchored in place, but the anchoring is insecure and the electrode tends to migrate away from the implantation site during body movement
Solution Approach 1:
The angled lead configuration creates a mechanical counterbalancing effect that preliminarily opposes the forces causing migration. By positioning the lead at an angle, the structure pre-compensates for body movement forces, reducing the tendency to migrate and enhancing both anchoring reliability and position stability.
4Ease of operation
If the paddle electrode is implanted with coplanar lead configuration, then the lead can be routed easily, but it is difficult to engage the paddle with the bony window to mechanically lock it in place
Solution Approach 1:
The lead wire configuration transitions from symmetric coplanar arrangement to an asymmetric angular orientation. This asymmetry creates a mechanical engagement advantage where the angled lead can be more easily locked into the bony window structure, resolving the contradiction between lead routing ease and engagement difficulty.
Data Source
AI summary
Disclosed is an electrode, such as an SCS paddle electrode, having a lead attached thereto along an interior portion of the electrode. The lead and electrode are configured such that the lead may be positioned generally coplanar with a top surface of the electrode, and may likewise be erected from such coplanar orientation up and away from the top surface of the electrode. Thus, the lead can maintain the typical configuration of emerging from the back end of the electrode, but because at least portions of the lead are not permanently bonded into the electrode paddle, the lead (when desired) can be pulled upward, with or without surrounding strain relief material, to emerge from the top surface of the paddle at an angle or curve to such top surface. This allows the base of the paddle to engage a bony opening, such as when the electrode is inserted into a patient's spine, skull, plane of fascia, etc.