Patent No. US10736688 (titled "Methods and systems for spinal radio frequency neurotomy") on Apr 14, 2016. The application was issued on Aug 11, 2020.
'688 is related to the field of thermal ablation, specifically radio frequency (RF) neurotomy. This technique involves using heat generated by RF energy to create necrosis in a targeted tissue volume, such as a nerve, to disrupt its function. A key challenge in thermal ablation is to precisely target the tissue while minimizing damage to surrounding structures. Spinal RF neurotomy, in particular, aims to cauterize nerves to block pain signals, but access limitations and anatomical variations make it difficult to create effective lesions with conventional RF probes.
The underlying idea behind '688 is to enhance the effectiveness and precision of RF neurotomy by using a needle with deployable filaments at its tip. These filaments, when extended, increase the active surface area from which RF energy emanates, creating a larger and more customizable lesion. The filaments can be retracted for insertion and precise placement of the needle tip, then deployed to expand the RF field, allowing for targeted ablation of nerves even in areas with limited access or anatomical variability. This approach overcomes the limitations of conventional single-electrode RF probes, which often struggle to create lesions of sufficient size and shape.
The claims of '688 focus on a system comprising an RF probe and a needle. The needle includes a hub, an elongate member with a lumen, a tissue-piercing tip, a plurality of filaments, and an actuator. The actuator controls the deployment and retraction of the filaments relative to the tip. A fitting, such as a Luer fitting, allows for fluid injection and insertion of the RF probe into the lumen. The key aspect is that the lumen is configured to allow the RF probe to physically contact a conductive portion of the needle, electrically connecting the probe to the tip and filaments. This arrangement enables the RF probe, tip, and filaments to function together as a monopolar RF electrode, with the filaments movable between retracted and deployed positions when the RF probe is not inserted.
In practice, the physician inserts the needle with the filaments retracted to a position near the target nerve, guided by imaging techniques like fluoroscopy. Once the tip is correctly positioned, the actuator is used to deploy the filaments, expanding the active RF energy delivery area. The RF probe is then inserted through the fitting and into the lumen, making electrical contact with the needle's conductive components. When RF energy is applied, it emanates from both the tip and the deployed filaments, creating a larger, more targeted lesion that ablates the nerve. The fluid injection capability allows for the delivery of anesthetics or contrast agents to further enhance the procedure.
This design differentiates itself from prior approaches by providing a means to customize the lesion size and shape without needing to reposition the needle multiple times. The deployable filaments allow for a larger ablation volume compared to standard RF probes, while the ability to retract them facilitates precise needle placement. The monopolar configuration simplifies the system, and the fluid injection capability adds another layer of utility. By increasing the active surface area for RF energy delivery, the invention enables more effective and targeted nerve ablation, potentially leading to improved pain relief for patients.
In the late 2000s when ’688 was filed, radio frequency neurotomy was typically implemented using a single probe that generated a fixed, oblate spheroid lesion. At a time when systems commonly relied on these single-point electrodes, achieving adequate coverage of target nerves was often difficult due to restricted angular access and natural anatomical variations. Hardware constraints made it non-trivial to expand the ablation volume without increasing the risk of collateral damage to surrounding structures, as the size of the thermal lesion was generally limited by the surface area of the active needle tip and the biophysical changes in the adjacent tissue.
The examiner allowed the claims because the prior art failed to disclose a needle system where the radio frequency probe makes physical contact with a conductive portion of the needle to electrically link the tip and multiple filaments. Specifically, the examiner noted that while previous designs used bipolar configurations, there was no technical motivation to modify those insulated components to be conductive for a monopolar setup. The examiner determined that the specific arrangement allowing the probe, needle tip, and deployed filaments to function together as a single monopolar electrode was not suggested by the existing technology, as doing so would have contradicted the intended use of the prior art's insulated assemblies.
This patent contains 74 claims, with independent claims 1, 53, and 56. The independent claims focus on a system comprising an RF probe and a needle with deployable filaments for RF ablation. The dependent claims generally elaborate on the specific features, configurations, and functionalities of the system components described in the independent claims.
Definitions of key terms used in the patent claims.
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