Needles And Systems For Radiofrequency Neurotomy

Patent No. US10966782 (titled "Needles And Systems For Radiofrequency Neurotomy") was filed by Stratus Medical Llc on Jul 20, 2020.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical landscape at the time

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.

Novelty and Inventive Step

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Conductive portion
(Claim 1, Claim 24, Claim 28)
“RF ablation uses electrical energy transmitted into a target volume through an electrode to generate heat in the area of the electrode tip. The radio waves emanate from a non-insulated distal portion of the electrode tip. The introduced radiofrequency energy causes molecular strain, or ionic agitation, in the area surrounding the electrode as the current flows from the electrode tip to ground.”A part of the radiofrequency neurotomy needle, located at its distal end, that is made of a material capable of conducting electricity and is designed to make physical and electrical contact with the radiofrequency probe.
Filament electrically connected
(Claim 1, Claim 24, Claim 28)
“RF ablation uses electrical energy transmitted into a target volume through an electrode to generate heat in the area of the electrode tip. The radio waves emanate from a non-insulated distal portion of the electrode tip. The introduced radiofrequency energy causes molecular strain, or ionic agitation, in the area surrounding the electrode as the current flows from the electrode tip to ground.”The filament is constructed of a conductive material and is physically connected to the tip such that electrical current can flow between them.
Monopolar mode
(Claim 1, Claim 24, Claim 28)
“In some embodiments, a needle comprises an elongate member having a distal end, a tip coupled to the distal end of the elongate member, and a plurality of filaments. The plurality of filaments and the tip are configured to transmit radio frequency energy from a probe to operate as a monopolar electrode.”A configuration where the radiofrequency energy is delivered through a single active electrode (the tip and filament) and returns through a separate grounding pad.
Radiofrequency neurotomy needle
(Claim 1, Claim 24, Claim 28)
“Thermal ablation involves the creation of temperature changes sufficient to produce necrosis in a specific volume of tissue within a patient. The target volume may be, for example, a nerve or a tumor. RF neurotomy uses RF energy to cauterize a target nerve to disrupt the ability of the nerve to transmit pain signals to the brain.”A needle specifically designed for radiofrequency neurotomy procedures, which involves ablating nerves using radiofrequency energy to disrupt pain signals.
Single electrode
(Claim 1, Claim 24, Claim 28)
“RF ablation uses electrical energy transmitted into a target volume through an electrode to generate heat in the area of the electrode tip. The radio waves emanate from a non-insulated distal portion of the electrode tip. The introduced radiofrequency energy causes molecular strain, or ionic agitation, in the area surrounding the electrode as the current flows from the electrode tip to ground.”The tip and filament of the radiofrequency neurotomy needle function together as a single electrical element to deliver radiofrequency energy.

Litigation Cases New

US Latest litigation cases involving this patent.

Case NumberFiling DateTitle
1:25-cv-00546May 2, 2025Stratus Medical, Llc V. Avanos Medical, Inc.

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US10966782

STRATUS MEDICAL LLC
Application Number
US16933811
Filing Date
Jul 20, 2020
Status
Granted
Expiry Date
May 4, 2031
External Links
Slate, USPTO, Google Patents