Paddle Neurostimulation Lead Delivery Tool for DRG Placement
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Solution Overview
Problem
The implant procedure for dorsal root ganglion (DRG) stimulation can be technically challenging due to scar tissue and anatomical constraints, such as the size of the foramen, which prevents the placement of a paddle lead.
Innovation Solution
A delivery tool with a delivery tube and stylet actuation mechanism is used to deploy and position a paddle neurostimulation lead proximate to the DRG, allowing for engagement and secure placement without requiring clear access through the foramen, utilizing a handle and stylet that can be advanced and retracted to facilitate the implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional stimulation lead is advanced through the foramen to reach the DRG, then the electrodes can be placed in proximity to the DRG, but scar tissue may prevent advancement through the foramen
Solution Approach 1:
The delivery system is divided into separate functional components: a delivery catheter for navigating to the target site, a stylet for engaging and securing the lead, and a release mechanism. This segmentation allows each component to perform its specific function independently, enabling successful implantation even when scar tissue blocks the traditional advancement path through the foramen.
Solution Approach 2:
The stylet acts as an intermediary tool that bridges the gap between the delivery catheter and the stimulation lead. It engages the engagement member on the lead and provides the necessary mechanical advantage to advance or reposition the lead when scar tissue creates resistance, solving the problem of difficult advancement through blocked foramina.
2Reliability
If the foramen size is small due to anatomical constraints, then access to the DRG is limited, but a paddle lead cannot be placed through the foramen
Solution Approach 1:
The stimulation lead is delivered through a nested configuration where the lead is contained within the delivery catheter, which is itself manipulated by the stylet and handle assembly. This nested arrangement allows the entire system to pass through small foramina that would be insufficient for direct paddle lead insertion, after which the lead can be deployed and positioned at the DRG target site.
Solution Approach 2:
The delivery system utilizes the longitudinal dimension by advancing the lead through the foramen in a stepwise manner using the stylet's engage-disengage mechanism, rather than requiring the lead to pass through in a single motion. This dimensional approach to delivery allows navigation through anatomically constrained pathways.
3Manufacturing precision
If a stylet is used to engage the paddle lead, then secure positioning is achieved, but the device complexity increases
Solution Approach 1:
The stylet is designed as a separate, removable component that can be extracted from the delivery catheter after the lead is successfully positioned. This extraction capability simplifies the overall system by allowing the stylet to be discarded or reused, rather than being a permanent part of the implant, thereby reducing the complexity of the final implanted device while maintaining positioning precision during the procedure.
Solution Approach 2:
The stylet performs its engagement and positioning function before being removed from the system. By concentrating the complex engagement mechanism into a preliminary action phase during implantation, the system achieves precise positioning without requiring the complex stylet mechanism to remain in place permanently, thus reducing overall device complexity.
Data Source
AI summary
The present disclosure provides systems and methods for deploying a paddle neurostimulation lead within a patient. A delivery tool includes a delivery tube including a first linear segment, a second linear segment, and an arcuate segment coupled between the first and second linear segments, the second linear segment defining an elongated opening. The delivery tool further includes a stylet positioned within an interior of the delivery tube, and a handle coupled to the delivery tube and including a stylet actuation mechanism, the stylet actuation mechanism configured to selectively advance and retract the stylet between a deployed position and a retracted position, wherein the stylet extends across the elongated opening in the deployed position to engage an engagement member of the paddle neurostimulation lead.