Vertebral Denervation Combined With Fusion for Hardware Pain
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Solution Overview
Problem
Existing treatments for chronic low back pain often fail to address multiple independent sources of pain, can exacerbate pain, require multiple interventions, and may lead to opioid dependence, while spinal fusion procedures can cause additional pain due to hardware and graft material.
Innovation Solution
A combined therapeutic procedure that includes spinal fusion and neuromodulation, such as basivertebral nerve ablation, performed in a single intervention to address multiple independent sources of pain, reducing the need for additional surgeries and opioid dependence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If spinal fusion procedure is performed, then pain caused by degenerative intervertebral discs is reduced, but additional pain is caused by hardware and graft material
Solution Approach 1:
The patent divides the pain treatment into separate addressable components: (1) spinal fusion to treat pain from degenerative discs and instability, and (2) neuromodulation to treat pain from hardware and graft material. This segmentation allows each modality to target specific pain sources without interfering with the other, resolving the contradiction by treating harmful effects separately from beneficial effects.
Solution Approach 2:
The patent introduces neuromodulation as an intermediary therapy that mediates the harmful pain signals generated by fusion hardware and graft material. By modulating nerve activity, this intermediary mechanism blocks pain transmission from hardware-related sources while preserving the stabilizing benefits of spinal fusion.
2Reliability
If existing treatments are used, then some pain sources are treated, but multiple independent sources of pain are not addressed
Solution Approach 1:
The patent merges two distinct treatment modalities—spinal fusion and neuromodulation—into a single comprehensive therapeutic approach. This combination allows simultaneous treatment of multiple independent pain sources: mechanical instability/degenerative disc pain through fusion, and neuropathic/hardware-related pain through neuromodulation, thereby resolving the limitation of addressing only single pain sources.
Solution Approach 2:
The patent creates a universal treatment protocol that can address diverse pain sources through a unified approach. The combined fusion-neuromodulation procedure serves multiple functions: stabilizing the spine, treating degenerative disc pain, managing hardware-related pain, and providing long-term relief from multiple independent pain generators, making it adaptable to complex multifactorial pain conditions.
3Stability of the object's composition
If spinal fusion is performed, then stabilization is provided, but bone remodeling around screws offsets load and increases pain
Solution Approach 1:
The patent applies preliminary neuromodulation before or during spinal fusion to preemptively address pain pathways that will be activated by subsequent bone remodeling and hardware presence. By modulating nerve activity in advance, the system prepares the nervous system to tolerate the mechanical changes and load redistribution that occur during fusion healing, reducing the perception of pain from these necessary physiological processes.
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
The combined procedure effectively reduces pain scores and increases patient satisfaction by synergistically addressing multiple pain sources, providing long-term relief without the need for further interventions and minimizing opioid use.
Implementation Method 1
The neuromodulation device may comprise a radiofrequency probe (e.g., bipolar radiofrequency probe) configured to deliver radiofrequency energy sufficient to modulate (e.g., ablate, denervate) the nerve.
Implementation Method 2
modulating a basivertebral nerve within the inner cancellous bone region using the neuromodulation device
Data Source
AI summary
Described herein are various implementations of systems and methods for treating back pain (e.g., chronic low back pain) caused by different (e.g., independent) sources of pain, such as pain originating or stemming from intervertebral discs, from vertebral endplates, and/or from intraosseous locations within one or more vertebral bodies. For example, methods for treating back pain (e.g., chronic low back pain) may involve both vertebral fusion (e.g., arthrodesis or spondylodesis to fuse adjacent vertebrae) and neuromodulation (for example, ablation of nerves within or surrounding one or more of the adjacent vertebrae). The neuromodulation may facilitate treatment of pain that is generated by insertion of fusion hardware.