Epidural Paddle Lead With Insertion Tab For Spinal Cord Stimulation
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Solution Overview
Problem
Conventional neurostimulation leads, particularly laminotomy leads, require invasive surgical procedures for implantation due to their dimensions and physical characteristics, which can lead to instability and migration post-implantation, and do not efficiently address bilateral pain as they create a uni-directional electrical field.
Innovation Solution
A paddle lead with an elongated shape and tabbed or extended portion is designed for implantation in the epidural space, featuring electrodes spaced to span the dorsal column and epidural space, allowing for adjustable electrode placement and suture anchoring to stabilize the lead and create a bidirectional electrical field.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional laminotomy leads are used, then electrodes can be positioned adjacent to the spinal cord, but the lead requires invasive surgical procedures and can migrate post-implantation
Solution Approach 1:
The paddle lead is nested within a delivery catheter during implantation. The catheter serves as a delivery vehicle that guides the paddle lead through the epidural space to the target position, after which the paddle lead is deployed from the catheter. This nesting approach simplifies the implantation procedure by providing a self-guiding system that reduces the need for invasive surgical exposure.
Solution Approach 2:
The paddle lead is pre-formed with a specific shape and flexibility characteristics that enable it to navigate through the epidural space and conform to the spinal cord anatomy before implantation. The lead's physical properties are prepared in advance to facilitate easy deployment and stable positioning without requiring complex surgical procedures.
2Ease of operation
If conventional percutaneous leads are used, then the implantation procedure is simpler, but the lead profile is small and positioning is less stable
Solution Approach 1:
The paddle lead incorporates a flexible yet stable structure that allows it to adapt to the epidural space anatomy while maintaining stable electrode positioning. The lead's dynamic properties enable it to conform to the spinal cord surface while resisting migration, providing both ease of implantation and long-term stability.
Solution Approach 2:
The paddle lead transitions from a thin percutaneous profile to a broader paddle structure that spans a wider area adjacent to the spinal cord. This dimensional change provides a larger surface area for electrode placement and creates a more stable platform that resists migration while still allowing for relatively simple implantation through the epidural space.
3Device complexity
If electrodes are arranged in a single column, then the lead structure is simpler, but the electrical field is uni-directional and cannot effectively address bilateral pain
Solution Approach 1:
The electrode array is segmented into multiple columns rather than a single column arrangement. This segmentation allows independent control of electrical stimulation in different spatial directions, enabling the creation of bidirectional electrical fields that can address pain on both sides of the body simultaneously while maintaining a manageable lead structure.
Solution Approach 2:
The multi-column electrode arrangement provides universal applicability for treating different types of pain conditions. By having electrodes distributed across multiple columns, the same lead design can effectively address unilateral pain, bilateral pain, and midline pain conditions, making the device versatile without requiring multiple different lead types.
Data Source
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AI summary
An implantable stimulation system including an epidural lead for spinal cord stimulation that Includes a paddle having an array of electrodes coupled to conductors within the paddle body. The paddle is elongated in shaped with the distal end of the paddle having a tabbed or extended portion with the lead exiting the extended portion of the paddle an angle relative to the longitudinal axis of the paddle.