Open Spinal Neuromodulation Implantation With DRG Lead Placement
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Solution Overview
Problem
Existing treatments for chronic spinal pain, including spinal procedures and neuromodulation, are often ineffective in resolving pain issues, requiring separate surgeries and prolonged use of pain medications, and lack a method for full visual and physical access during implantation.
Innovation Solution
A combined surgical procedure that integrates spinal fusion with neuromodulation device implantation, allowing for open access to the spinal treatment site for precise placement of neuromodulation leads and generators, eliminating the need for anatomical advancement and enabling immediate or delayed neuromodulation therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate spinal procedures and neuromodulation implantation are performed, then each procedure can be optimized independently, but the overall treatment time and patient recovery period increase
Solution Approach 1:
The patent combines spinal fusion surgery and neuromodulation device implantation into a single surgical procedure. The spinal fusion addresses structural instability while the neuromodulation device (with leads positioned at dorsal root ganglia) addresses neuropathic pain, merging two previously separate treatments into one comprehensive solution that reduces total treatment time and patient recovery period
2Ease of operation
If traditional epidural access methods are used for neuromodulation lead placement, then the procedure can be performed with less invasive access, but full visual and physical access to the spinal treatment site is not achieved
Solution Approach 1:
The surgical approach segments the spinal access into multiple levels, opening the spinal canal at specific vertebral levels to provide direct visual and physical access to the spinal treatment site. This segmentation allows the surgeon to precisely locate and access the dorsal root ganglia for lead placement while maintaining the benefits of a controlled surgical environment
Solution Approach 2:
The patent transitions from traditional epidural access (one-dimensional, through soft tissue) to a multi-dimensional approach by opening the bony spinal canal and creating direct access to the spinal treatment site. This dimensional change enables precise visualization and placement of leads at the dorsal root ganglia while providing full physical and visual access to the treatment area
3Reliability
If multiple separate surgeries are performed for spinal stabilization and pain management, then each treatment can be optimized, but the cumulative risk and patient burden increase
Solution Approach 1:
The combined surgical procedure serves multiple functions simultaneously: it provides spinal stabilization through fusion, places neuromodulation leads at the dorsal root ganglia for pain management, and establishes access for potential future interventions. This multi-functionality reduces the number of separate procedures needed while maintaining optimized treatment effectiveness for both structural and neuropathic pain
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 minimizes the need for pain medications, including opioids, by addressing both back stabilization and neuropathic pain in a single procedure, ensuring optimal lead placement and reducing post-surgical pain.
Implementation Method 1
the neuromodulation system may generate electrical stimulation during and/or after the surgical procedure
Data Source
AI summary
The present invention provides a single surgical method, procedure and/or system that creates open visual and physical access to an identified spinal treatment site that initially comprises spinal levels to be treated, wherein the spinal levels comprise at least one dorsal root ganglion. A spinal treatment procedure is performed generally in combination with implantation of a neuromodulation system that may comprise placement of electrical lead(s) on the at least one dorsal root ganglion, wherein each lead is in operative connection with a pulse generator that may also be implanted during the surgical method. Electrical stimulation may be generated with the pulse generator through the electrical leads to the at least one dorsal root ganglion during and/or after the closure of the identified spinal treatment site.


