Open-Site DRG Lead Placement During Spinal Fusion Surgery
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Solution Overview
Problem
Existing treatments for chronic spinal pain, particularly after failed back surgery, often require separate procedures for spinal fusion and neuromodulation, which do not fully address neuropathic pain and necessitate extensive use of pain medications.
Innovation Solution
A combined surgical procedure that allows for both spinal stabilization and neuromodulation implantation in a single operation, with full visual and physical access to the treatment site, enabling direct placement of neuromodulation leads and electrodes without internal advancement, and the option for immediate or delayed neuromodulation therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate procedures are performed for spinal fusion and neuromodulation, then each procedure can be optimized independently, but the patient requires multiple surgeries and extensive use of pain medications
Solution Approach 1:
The patent combines spinal fusion and neuromodulation implantation into a single surgical procedure. The surgeon performs the spinal fusion surgery and, while the surgical site is already open, implants the neuromodulation system (leads, electrodes, and pulse generator) during the same operation. This eliminates the need for separate staged procedures and reduces overall treatment time.
2Ease of manufacture
If traditional neuromodulation implantation is performed after failed back surgery, then the spinal procedure is completed, but the patient continues to experience neuropathic pain requiring ongoing medication
Solution Approach 1:
The patent applies preliminary action by implanting the neuromodulation system during the initial spinal fusion surgery, before the patient experiences prolonged chronic pain. The pulse generator can be programmed to provide stimulation immediately or after a brief healing period, preventing the development of severe neuropathic pain and medication dependence that typically occurs with delayed implantation.
3Measurement precision
If neuromodulation leads are advanced through internal anatomy to reach therapeutic locations, then the leads can be positioned at the target site, but the procedure becomes more complex and risky
Solution Approach 1:
The patent extracts the leads from the complex internal advancement pathway and places them directly at the therapeutic location through the already-open surgical site. Instead of threading leads through tunnels and anatomical structures, the surgeon can directly position the electrodes near the spinal cord or dorsal root ganglia while the back is surgically exposed, dramatically simplifying the implantation process.
4Strength
If spinal fusion is performed without concurrent neuromodulation implantation, then the spinal stabilization is achieved, but post-surgical pain management requires extensive medication use
Solution Approach 1:
The patent converts the surgical exposure required for spinal fusion (which inherently involves tissue disruption and pain) into a benefit by using the same incision and exposure to implant the neuromodulation system. The surgical access that causes harm (pain, recovery time) is simultaneously used to deliver the pain-relieving therapy, turning a negative aspect into a positive opportunity.
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
Minimizes the need for pain medications by treating both back stabilization and neuropathic pain in a single procedure, reducing post-surgical pain and potentially eliminating the need for opioids.
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.