Patent No. US10925664 (titled "Methods For Radio Frequency Neurotomy") was filed by Stratus Medical Llc on Jul 20, 2020.
’664 is related to the field of thermal ablation systems, specifically radio frequency (RF) neurotomy. This technique aims to disrupt a nerve's ability to transmit pain signals to the brain by cauterizing the target nerve with RF energy. Existing methods often struggle with limited access to the target nerve and anatomical variations, making it challenging to create lesions of sufficient size and optimal clinical outcomes while sparing surrounding tissue.
The underlying idea behind ’664 is to enhance RF neurotomy by using a specialized needle with deployable filaments that extend from the tip. These filaments increase the effective surface area for RF energy delivery, creating a larger and more customizable lesion volume. By manipulating the position and orientation of these filaments, the physician can precisely target the desired nerve tissue while minimizing damage to surrounding structures.
The claims of ’664 focus on a method involving inserting a needle with an elongate member, a piercing tip, a lumen, and a retractable filament. The method includes moving the filament to a deployed position where its distal end extends beyond the elongate member and away from the tip. A radiofrequency probe is then inserted into the needle's lumen, establishing electrical contact with a conductive portion of the needle at its distal end. Finally, the radiofrequency probe, the tip, and the filament are operated as a monopolar electrode , with RF energy from the probe conducted to the filament and transmitted into the surrounding tissue.
In practice, the physician navigates the needle to a position near the target nerve using imaging guidance. Once in place, the filaments are deployed, expanding the area of RF energy delivery. The RF probe, inserted through the needle's lumen, then delivers energy to the tip and filaments, creating a lesion that ablates the target nerve. The ability to adjust the filament deployment allows for tailoring the lesion's size and shape to the specific anatomical context.
’664 differentiates itself from prior approaches by overcoming the limitations of conventional single-electrode RF probes. The multiple filaments provide additional conduits for RF energy, creating a multipolar RF field effect. This allows for larger and more customizable lesions, addressing the challenges of limited access and anatomical variations. The invention also enables the creation of lesions offset from the needle's axis, facilitating precise targeting of nerves near sensitive structures.
In the late 2000s when ’664 was filed, thermal ablation was typically implemented using radiofrequency (RF) energy delivered through electrodes to create lesions in targeted tissues. At a time when precise control of lesion size and shape was a significant challenge, systems commonly relied on thermocouples for temperature feedback. The limited access to target nerves and anatomical variations made creating sufficient lesions non-trivial.
The examiner allowed the claims because prior art references such as Young, Edwards, and Tullis, either alone or in combination, do not disclose all the method steps as claimed in the independent claims. Specifically, these references fail to teach inserting a radiofrequency probe into the lumen of a needle such that the RF probe contacts a conductive portion of the needle at a distal end, and operating the radiofrequency probe, the tip, and the filament as a monopolar electrode. Furthermore, Edwards and Tullis teach away from using a monopolar configuration, as they disclose bipolar configurations.
This patent contains 29 claims, with independent claims 1 and 21. The independent claims are directed to methods involving inserting a needle with a filament into a patient, deploying the filament, inserting a radiofrequency probe into the needle to contact a conductive portion, and operating the probe and filament as a monopolar electrode. The dependent claims generally elaborate on specific aspects, features, or steps of the methods described in the independent claims.
Definitions of key terms used in the patent claims.
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