Percutaneous Tripole Electrode Array for Spinal Cord Stimulation
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Solution Overview
Problem
Current methods for implanting transverse tripole electrode arrays for neurological stimulation require invasive procedures or multiple needle punctures for individual lead placement, making them time-consuming and undesirable.
Innovation Solution
A single implantable medical electrical lead with a tri-pole electrode array designed for percutaneous implantation through a standard needle, featuring a center electrode and lateral electrodes supported by the lead's sides, and a self-expanding introducer system for precise placement without multiple needle sticks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If three separate electrode carrying leads are individually implanted through multiple needle punctures to achieve transverse tripole contact arrangement, then the electrode array can be properly positioned for neurological stimulation, but the procedure becomes time-consuming and complex
Solution Approach 1:
The patent combines three separate electrode leads into a single integrated lead body with multiple electrodes positioned at the distal end. The lead body contains a first electrode, second electrode, and third electrode arranged to provide transverse tripole contact arrangement, eliminating the need for multiple separate implantation procedures while maintaining precise electrode positioning for neurological stimulation.
Solution Approach 2:
The lead body is segmented into distinct electrode elements (first, second, and third electrodes) positioned at specific locations along the distal end. This segmentation allows each electrode to be independently positioned and activated, enabling flexible stimulation patterns while being delivered through a single minimally invasive access point.
2Reliability
If surgical paddle type lead is used to provide multiple transverse tripole contacts, then the electrode array can be implanted, but invasive open surgical techniques such as laminotomy or laminectomy are required
Solution Approach 1:
The patent merges multiple electrode functions into a single percutaneously implantable lead, eliminating the need for open surgical procedures. The integrated lead body with multiple electrodes at the distal end provides the same transverse tripole contact arrangement as surgical paddle leads but can be delivered through a minimally invasive single needle stick procedure.
Solution Approach 2:
The lead body acts as an intermediary device that delivers multiple electrodes through a single percutaneous access point. This intermediary structure allows the electrodes to be positioned adjacent to the spinal cord without requiring open surgical exposure, thereby reducing surgical invasiveness while maintaining effective electrode implantation.
3Adaptability or versatility
If multiple separate leads are used to provide transverse tripole contacts, then reprogramming flexibility is achieved, but the implantation procedure becomes challenging and complex
Solution Approach 1:
The patent combines multiple electrode contacts into a single lead body, simplifying the implantation procedure to a single percutaneous access point. The lead body contains first, second, and third electrodes that can be independently activated and programmed, maintaining reprogramming flexibility while reducing implantation complexity from multiple separate lead insertions to one integrated device placement.
Data Source
AI summary
Lead devices and methods for neurostimulation are described. Some of the neurostimulation leads provided have multiple, distal region electrode contacts arranged in an array capable of providing steerable spinal cord stimulation. In one use, a collapsed introducer sheath is disposed over a dilator and advanced to a spinal cord target site through a 14-gauge needle into the epidural space. The dilator is removed and the introducer is expanded to its full width. A neurological lead according to the present invention advanced through the introducer to near the target site and the introducer removed. The lead is wider than it is high and has a row of lower electrodes flanked by right and left side electrodes in groups of three. The lower electrodes serve as cathodes and the right and left electrodes are return anodes.