Foldable Medical Electrode for Minimally Invasive Epidural Insertion
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Solution Overview
Problem
The implantation of paddle electrode devices in the epidural space of the spinal column is challenging due to their transverse extension, requiring surgical intervention and vertebral body removal to create sufficient space.
Innovation Solution
A medical electrode device with an adjustable electrode end that can be folded to reduce its radial extension, allowing it to be inserted through the epidural space like an isodiametric electrode. The electrode end is retained in a folded position using a retaining device that interacts with a mandrel, and is actuated to unfold at the desired location.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of stationary object
If a paddle electrode is used with a transverse extension at the electrode end, then the contact area with surrounding tissue is improved, but the implantation difficulty increases due to inability to push through the epidural space
Solution Approach 1:
The electrode end is designed to be dynamically changeable between a folded configuration (for insertion) and an unfolded configuration (for contact). The retaining device enables this dynamic transformation, allowing the electrode to adapt its geometry based on the implantation stage, thereby resolving the contradiction between maintaining large contact area and achieving easy insertion.
Solution Approach 2:
The electrode end is segmented into multiple contact elements that can be independently folded or unfolded. This segmentation allows the electrode to be compressed into a compact form for insertion while expanding to provide extensive contact area once positioned, effectively resolving the space conflict during implantation.
2Area of stationary object
If a paddle electrode is implanted by surgical placement, then sufficient space is provided for electrode insertion, but the surgical complexity and tissue damage increase
Solution Approach 1:
By making the electrode end dynamically foldable, the device eliminates the need for surgical creation of space. The electrode can be inserted through the natural epidural space in a compact folded state and then unfolded at the target location, thereby reducing surgical complexity and avoiding vertebral body removal while still providing adequate contact area.
Solution Approach 2:
The folded electrode end configuration allows the electrode to be nested within or alongside the lead body during insertion, similar to nested dolls. This nesting approach enables passage through the confined epidural space without requiring additional surgical space, thereby reducing surgical complexity.
3Ease of operation
If the electrode end is kept unfolded during insertion, then contact elements are immediately available, but the radial extension prevents passage through the epidural space
Solution Approach 1:
The electrode end transitions dynamically from a compact folded state during insertion to an unfolded state for contact. The retaining device controls this transition, ensuring the electrode is folded during passage through the epidural space (reducing radial extension) and then unfolded at the target location (making contact elements available), thus resolving the contradiction between insertion feasibility and contact availability.
Solution Approach 2:
The electrode end is pre-folded into a compact configuration before insertion to enable passage through the epidural space. The unfolding action is performed as a preliminary step after insertion but before full contact engagement, allowing the electrode to first navigate the constrained space and then expand to provide contact elements at the desired location.
Data Source
AI summary
A medical electrode device for implantation into a patient comprises a lead body extending along a longitudinal axis and having a proximal end, a distal end and an inner lumen for receiving a mandrel. An electrode end is arranged at the distal end of the lead body and comprises a carrier element and an arrangement of contact elements arranged on the carrier element for contacting tissue. A retaining device is arranged on the electrode end and is configured to interact with the mandrel, wherein the electrode end is adjustable between a folded position and an unfolded position, the retaining device being configured to retain the electrode end in the folded position and being actuatable for causing the electrode end to transfer from the folded position to the unfolded position.