Patent No. US10966782 (titled "Needles And Systems For Radiofrequency Neurotomy") was filed by Stratus Medical Llc on Jul 20, 2020.
’782 is related to the field of thermal ablation , specifically systems and methods for radiofrequency (RF) neurotomy, such as spinal RF neurotomy. The background acknowledges the challenge of providing adequate treatment to targeted tissue, like nerves, while sparing surrounding structures from injury. RF ablation uses electrical energy to generate heat, and RF neurotomy specifically aims to cauterize nerves to disrupt pain signal transmission.
The underlying idea behind ’782 is to improve the precision and control of RF neurotomy by using a needle with deployable filaments . These filaments extend from the needle tip to create a larger, more directional, and customizable ablation zone. By adjusting the position and configuration of the filaments, the energy can be focused on the target nerve while minimizing damage to surrounding tissues.
The claims of ’782 focus on a system comprising a radiofrequency probe and a radiofrequency neurotomy needle. The needle has a conductive portion at its distal end, a tissue-piercing tip, an elongate member with a lumen to accept the RF probe, and at least one filament. The filament is electrically connected to the tip and is movable between a retracted and a deployed position. An actuator controls the filament's movement. The key aspect is that the filament and tip operate together as a single monopolar electrode when the RF probe is inserted and the filament is deployed.
In practice, the surgeon inserts the needle near the target nerve. Then, the actuator is used to deploy the filaments, expanding the effective area of RF energy delivery. The filaments and tip then act as a single electrode, creating a larger, more controlled lesion. The ability to adjust the filament deployment allows for customization of the lesion shape and direction , directing energy towards the target nerve and away from sensitive structures.
This design differentiates itself from prior approaches by providing a more precise and controllable ablation zone. Traditional RF ablation often struggles with creating lesions of the desired size and shape without damaging surrounding tissue. The deployable filaments allow for a larger, offset lesion that can be tailored to the specific anatomy, potentially leading to more effective pain relief and fewer complications. The design also allows for a smaller needle size, reducing trauma during insertion.
In the early 2010s when ’782 was filed, radiofrequency (RF) ablation was a well-established technique for creating temperature changes sufficient to produce necrosis in a specific volume of tissue. At a time when RF ablation was typically implemented using electrodes to deliver energy to a target volume, a significant challenge was providing adequate treatment to the targeted tissue while sparing the surrounding structures from injury.
The examiner allowed the claims because the prior art, specifically Tullis et al. and Young et al., did not teach or fairly suggest all the limitations of the independent claims. While these references disclosed similar systems comprising a radiofrequency neurotomy needle operable with a radiofrequency probe and deploying filaments, they failed to teach the specific configuration where the radiofrequency probe physically contacts and is electrically connected to a conductive portion of the needle, with the filament and tip operating together as a single electrode in a monopolar mode when the filament is deployed and the probe is in contact with the conductive portion.
This patent contains 29 claims, with independent claims numbered 1, 24, and 28. The independent claims are directed to systems comprising a radiofrequency probe and a radiofrequency neurotomy needle with a movable filament and a tip that operate together as a single electrode. The dependent claims generally elaborate on specific features, configurations, and functionalities of the system described in the independent claims.
Definitions of key terms used in the patent claims.
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