Dorsal Root Ganglia Paddle Lead with Living Hinge
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Solution Overview
Problem
Conventional paddle leads for spinal cord stimulation require large incisions and substantial removal of lamina, leading to trauma and longer procedure times, while also being difficult to deploy minimally invasively.
Innovation Solution
The development of dorsal root ganglia stimulation leads with a paddle body that tapers to a distal tip, allowing for surgical placement below vertebral lamina, and featuring a living hinge and suture loop configuration for flexible and minimally invasive deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional paddle leads are delivered through laminectomy, then the leads can be positioned along the dura layer, but this requires large incisions and substantial removal of lamina causing patient trauma and longer procedure time
Solution Approach 1:
The paddle lead is divided into modular segments that can be delivered through a minimally invasive approach. The lead body is segmented into a proximal shaft and a distal paddle portion, allowing the paddle to be deployed separately through a smaller surgical opening while maintaining stable positioning along the dura layer.
Solution Approach 2:
The paddle lead is nested within a delivery catheter system that guides it through the spinal anatomy. The lead body is inserted through the catheter, and the paddle portion is deployed from the catheter tip, enabling minimally invasive placement while ensuring accurate positioning along the dura layer.
2Reliability
If conventional paddle leads are delivered through laminectomy, then the leads can be positioned along the dura layer, but this results in longer procedure time
Solution Approach 1:
The paddle lead is pre-shaped and pre-configured within the delivery catheter before insertion. The paddle portion is pre-formed to match the curvature of the spinal canal, eliminating the need for time-consuming intraoperative shaping or adjustment after placement.
Solution Approach 2:
The delivery catheter system incorporates dynamic features that allow real-time adjustment of the lead position during insertion. The catheter can be flexed and repositioned to navigate the spinal anatomy efficiently, reducing the time required to achieve optimal lead placement.
3Object-affected harmful factors
If paddle leads are designed for minimally invasive delivery, then patient trauma is reduced, but the leads may migrate once implanted
Solution Approach 1:
The paddle lead incorporates localized features at the distal end, such as flanges or anchoring elements, that provide enhanced stability and prevent migration. These local structural modifications are concentrated at the insertion site where they are most needed, while the rest of the lead maintains a streamlined profile for minimally invasive delivery.
Solution Approach 2:
The paddle lead is constructed from composite materials that combine flexibility for minimally invasive delivery with rigidity for stable positioning. The lead body uses a flexible polymer for navigation, while the paddle portion incorporates a stiffer material or structural reinforcement to resist migration once deployed.
4Object-affected harmful factors
If percutaneous leads are used, then minimally invasive delivery is achieved, but they provide less stable positioning and require more energy
Solution Approach 1:
The paddle lead design copies the stable positioning characteristics of traditional laminectomy-delivered leads while maintaining the minimally invasive delivery approach. The paddle geometry and electrode arrangement are optimized to replicate the mechanical stability and electrical performance of conventional leads without requiring large surgical openings.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enables the minimally invasive implantation of paddle leads, reducing patient trauma and procedure time, while providing focused electrical stimulation to the dorsal root ganglion with improved stability and reduced power consumption.
Implementation Method 1
electrical stimulation of the dorsal root ganglion
Data Source
AI summary
Implementations described and claimed herein provide paddle leads for dorsal root ganglia (DRG) stimulation and methods of implanting the same. In one implementation, the paddle lead has a small profile facilitating deployment into a target space in the neuroforamen dorsal to the DRG and below the vertebral lamina. A paddle body of the paddle lead may include a living hinge and/or a contoured profile to further facilitate implantation in the target space. For suture assisted deployment as well as to resist migration of the paddle lead once deployed, the paddle lead may include a suture loop configuration. The paddle lead further includes an electrode array having electrode contacts arranged in a two dimensional configuration pattern to create an electrical field optimized for stimulation of the DRG.